Class IIMedicationJul 9, 2026
CareFusion 213, LLC: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123,…
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Product, lots & distribution
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31 — Distribution: U.S.A. Nationwide — Lots/codes: Lots: 4062535, 4065201, 4066446, Exp. 2/28/2027; 4141090, Exp. 5/31/2027; 4180288, 4197695, 4197697, 4180291, Exp. 6/30/2027; 4219454, 4221945, 4221966, 4222853, 4224361, Exp. 7/31/2027; 4228482, 4248656, 4249026, 4248961, 4249818, 4250729, Exp. 8/31/2027; 5124984, 5127231, 5129058, 5126398, 5129488, Exp. 4/30/2028; 5130576, 5142947, 5147432, 5154673, 5154671, 5156442, 5157968, 5158031, 5150160, 5155824, Exp. 5/31/2028; 5176326, 5181676, 5181074, 5182660, 5188102, 5188103, Exp. 6/30/2028; 5195818, 5199118, 5209474, 5210853, 5211985, 5211907, 5211212, Exp. 7/31/2028; 5226576, 5227151, 5230531,… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJul 6, 2026
Chiesi USA, Inc.: CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Aust…
Lack of Assurance of Sterility
Product, lots & distribution
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 1239521, 1237454, Exp. Date 10/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 29, 2026
Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard,…
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Product, lots & distribution
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-410-02 — Distribution: USA Nationwide — Lots/codes: Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 29, 2026
Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard,…
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Product, lots & distribution
Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-411-02 — Distribution: USA Nationwide — Lots/codes: Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 29, 2026
Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard,…
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Product, lots & distribution
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02 — Distribution: USA Nationwide — Lots/codes: Lot #: 5PB0563, Exp 4/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 26, 2026
Lannett Company Inc.: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distri…
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Product, lots & distribution
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37. — Distribution: US Nationwide. — Lots/codes: Lot#: 25285401A, Exp. Date: 04/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 25, 2026
Bell Pharmaceuticals, Inc: CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy.,…
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product, lots & distribution
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895, — Distribution: U.S Nationwide — Lots/codes: Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 25, 2026
Bell Pharmaceuticals, Inc: Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15…
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product, lots & distribution
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01. — Distribution: U.S Nationwide — Lots/codes: Lot: a) 1504241, exp 2027-03; b) 1504291, 1504301, exp 2027-03. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 25, 2026
Bell Pharmaceuticals, Inc: QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc.,…
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product, lots & distribution
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376. — Distribution: U.S Nationwide — Lots/codes: Lot: a) 1505121, 1505342, exp 2027-04; b) 1505381, exp 2027-04. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 25, 2026
Bell Pharmaceuticals, Inc: TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO AS…
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product, lots & distribution
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. — Distribution: U.S Nationwide — Lots/codes: Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 25, 2026
Bell Pharmaceuticals, Inc: AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree P…
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product, lots & distribution
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005. — Distribution: U.S Nationwide — Lots/codes: Lot: a)1505123, expires: 2027-04; b) 1505131, expires: 2027-04. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 25, 2026
Bell Pharmaceuticals, Inc: FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE,…
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product, lots & distribution
FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320. — Distribution: U.S Nationwide — Lots/codes: Lot: 1505124, 1505311, 1505332, expires: 2027-04. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 25, 2026
Bell Pharmaceuticals, Inc: GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: Ameri…
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product, lots & distribution
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428. — Distribution: U.S Nationwide — Lots/codes: Lot: a) 1505334, expires: 2027-04; b) 1505143, 1505151, expires: 2027-04 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 25, 2026
Bell Pharmaceuticals, Inc: LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HE…
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product, lots & distribution
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017. — Distribution: U.S Nationwide — Lots/codes: Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 25, 2026
Bell Pharmaceuticals, Inc: Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product, lots & distribution
Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141. — Distribution: U.S Nationwide — Lots/codes: Lot:1505161, 1505181, 1505301, 1505382, exp 2027-04. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 25, 2026
Bell Pharmaceuticals, Inc: meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product, lots & distribution
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. — Distribution: U.S Nationwide — Lots/codes: Lot:1505344, exp 2027-04. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 25, 2026
Bell Pharmaceuticals, Inc: CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product, lots & distribution
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785. — Distribution: U.S Nationwide — Lots/codes: Lot:1505141, exp 2027-04. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 24, 2026
QuVa Pharma, Inc.: Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1…
Failed Impurities/Degradation Specifications
Product, lots & distribution
Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 10162261, 10162262, 10162279, 10162280, Exp. Date 07/21/2026; 10162314, 10162315, Exp. Date 07/22/2026; 10162465, 10162466, 10162491, 10162492, Exp. Date 07/26/2026; 10162542, 10162543, Exp. Date 07/27/2026; 10162559, 10162560, Exp. Date 07/28/2026; 10162623, 10162624, Exp. Date 07/29/2026; 10162693, 10162694, Exp. Date 07/30/2026; 10162735, 10162736, 10162753, 10162754, Exp. Date 07/31/2026; 10162772, 10162773, 10162791, 10162792, 10162810, 10162811, Exp. Date 08/02/2026; 10162820, Exp. Date 08/03/2026; 10162853, 10162854, Exp. Date 08/04/2026; 10163046, Exp. Date 08/09/2026; 10163156… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 24, 2026
Reliance Life Sciences Private Limited: Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Som…
Lack of Sterility Assurance
Product, lots & distribution
Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: RPTL0325A Dec 31, 2027; RPTL0425A Dec 31, 2027; RPTL0624B Nov 30,2027; RPTL0625A Mar 31, 2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 24, 2026
Reliance Life Sciences Private Limited: Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Som…
Lack of Sterility Assurance
Product, lots & distribution
Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028; — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 24, 2026
Reliance Life Sciences Private Limited: Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset,…
Lack of Sterility Assurance
Product, lots & distribution
Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 24, 2026
Reliance Life Sciences Private Limited: Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeuti…
Lack of Sterility Assurance
Product, lots & distribution
Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 24, 2026
Bear Stewart Co: Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough, 8-oz pouch 12 cookies per pouch, UPC 8 50073 08700 8, 8 pouches per case
undeclared soy
Product, lots & distribution
Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough, 8-oz pouch 12 cookies per pouch, UPC 8 50073 08700 8, 8 pouches per case — Distribution: The recalled Bakr Brown Butter Chocolate Chunk Ready To Bake Cookie Dough was distributed in Southern California, Southern Nevada, Arizona, and Utah through Target retail stores starting on June 11, 2026. — Lots/codes: Lot Code: 2606022 Expiration Date: 06/02/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 23, 2026
Padagis US LLC: Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Product, lots & distribution
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35 — Distribution: USA Nationwide — Lots/codes: Lot #: 205060, Exp 09/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 23, 2026
Lupin Pharmaceuticals Inc.: Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals,…
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Product, lots & distribution
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01 — Distribution: Nationwide within the U.S. — Lots/codes: Kit Lots: WB00010, Exp. Date Jan 2027; WB00017, WB00019, Exp. Date Feb 2027; WB00070, Exp. Date Jun 2027; WB00077, WB00078, Exp. Date Jul 2027; WB00130, Exp. Date Nov 2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 22, 2026
Direct Rx: DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product, lots & distribution
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx. — Distribution: U.S. Nationwide — Lots/codes: Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 22, 2026
AMY'S KITCHEN INC.: Amy's ORGANIC SOUPS LENTIL LIGHT IN SODIUM NET WT. 14.5 OZ. (411 g) Microwave: Place soup in a microwave-safe bowl. Cover. Cook for 1.5-2 minutes. Let sit 1 minute. Stir. Serve. S…
Potential for spoilage.
Product, lots & distribution
Amy's ORGANIC SOUPS LENTIL LIGHT IN SODIUM NET WT. 14.5 OZ. (411 g) Microwave: Place soup in a microwave-safe bowl. Cover. Cook for 1.5-2 minutes. Let sit 1 minute. Stir. Serve. Stovetop: Heat soup in a saucepan, stirring occasionally. AMY'S KITCHEN, INC. P.O. BOX 7129 PETALUMA, CA 94955 UPC (for U.S. product): 042272005833 UPC (for Canada product): 10042272905833 — Distribution: Domestic: AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, MD, ME, MI, MO, NC, NH, NJ, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI. Foreign: Canada. — Lots/codes: LOT: 60D0924 BEST BEFORE: 4/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 19, 2026
General Mills James Ford Bell Technical Center: Pillsbury Bread Rolls, Hard Roll Dough. 180 units / 2.25oz each. Net Wt. 25.31 lb (11.48kg) Package UPC 721582-13283 4. Case UPC 107-21582-13283-1. Kee…
Potential foreign material (glass)
Product, lots & distribution
Pillsbury Bread Rolls, Hard Roll Dough. 180 units / 2.25oz each. Net Wt. 25.31 lb (11.48kg) Package UPC 721582-13283 4. Case UPC 107-21582-13283-1. Keep Frozen. Case Qty 180. Distributed by: General Mills Sales, Inc. Minneapolis, MN 55440. — Distribution: AR, CA, FL, GA, IN, LA, ME, MO, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WY — Lots/codes: Better if Used by OCT 12 26 / Lot: 11JUN6JL Better if Used by OCT 13 26 / Lot: 12JUN6JL — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 19, 2026
General Mills James Ford Bell Technical Center: Pillsbury Bread Rolls, Kaiser Roll Dough. 144 units / 2.5oz each. Net Wt. 22.5 lb (10.2kg) Package UPC 7 21582-13288 9. Case UPC 107-21582-13288-6. Kee…
Potential foreign material (glass)
Product, lots & distribution
Pillsbury Bread Rolls, Kaiser Roll Dough. 144 units / 2.5oz each. Net Wt. 22.5 lb (10.2kg) Package UPC 7 21582-13288 9. Case UPC 107-21582-13288-6. Keep Frozen. Case Qty 144. Distributed by: General Mills Sales, Inc. Minneapolis, MN 55440. — Distribution: AR, CA, FL, GA, IN, LA, ME, MO, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WY — Lots/codes: Better if Used by OCT 13 26 / Lot: 12JUN6JL — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 19, 2026
Fayus Inc.: OLA-OLA POUNDED GROUNDNUTS (INTWILO) NET WT. 32 oz., 2 lbs. (0.907 kg) Distributed by: Yusol International Foods Sacramento, CA 95828 Product of USA INGREDIENTS: Pounded Groundnuts (Intwi…
Undeclared peanuts
Product, lots & distribution
OLA-OLA POUNDED GROUNDNUTS (INTWILO) NET WT. 32 oz., 2 lbs. (0.907 kg) Distributed by: Yusol International Foods Sacramento, CA 95828 Product of USA INGREDIENTS: Pounded Groundnuts (Intwilo) UPC: 650655764330 — Distribution: Domestic: TX. Foreign: Not Applicable. — Lots/codes: Lots: L536531; L500505 Exp: 12/28 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 18, 2026
MARS SNACKING: MorningStar Farms Buffalo Chik'n Nuggets, 100% Plant Protein Vegan Nuggets, Net Wt. 10.5 oz. (298g), packaged in a resealable plastic bag with UPC 028989101105, packed 6 bags per case
Potential contamination with plastic material
Product, lots & distribution
MorningStar Farms Buffalo Chik'n Nuggets, 100% Plant Protein Vegan Nuggets, Net Wt. 10.5 oz. (298g), packaged in a resealable plastic bag with UPC 028989101105, packed 6 bags per case — Distribution: AL, AR, AZ, CA, CO, CT, FL GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TX, TN, UT, VA, VT, WA, WI, WY, and Puerto Rico — Lots/codes: Best If Used By: JUL 07 2027, JUL 08 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 18, 2026
MARS SNACKING: MorningStar Farms Hot & Spicy Sausage Patties, 100% Plant Protein Vegan Sausage Patties, Net Wt. 8 oz. (228g), packaged in a resealable plastic bag with UPC 028989100948, packed 6 bags…
Potential contamination with plastic material
Product, lots & distribution
MorningStar Farms Hot & Spicy Sausage Patties, 100% Plant Protein Vegan Sausage Patties, Net Wt. 8 oz. (228g), packaged in a resealable plastic bag with UPC 028989100948, packed 6 bags per case — Distribution: AL, AR, AZ, CA, CO, CT, FL GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TX, TN, UT, VA, VT, WA, WI, WY, and Puerto Rico — Lots/codes: Best If Used By: JUL 05 2027, JUL 06 2027, JUL 07 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 18, 2026
Provision Health Corp. dba PH Labs: Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9; Dietary Supplement, 200 Capsules. Serving Size: 4 Capsules; Distributed by: L.A. Farmacia Natural, Burbank, C…
Dietary supplement product Ocular Plus contains undeclared Yellow#5.
Product, lots & distribution
Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9; Dietary Supplement, 200 Capsules. Serving Size: 4 Capsules; Distributed by: L.A. Farmacia Natural, Burbank, CA 91504 UPC: PHF-C023 — Distribution: Product was distributed to two local direct accounts. Both are local retail stores selling various vitamins and health products. — Lots/codes: Lots: 509011; 506013; 409012; Expiration: 09/27; 06/27; 09/26 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 18, 2026
Provision Health Corp. dba PH Labs: Vista MAX; Dietary Supplement, 90 Capsules. Serving Size: 4 Capsules; Distributed by: Vision of Health, Bell, CA 90201 UPC: PHF-C023
Dietary supplement product Vista MAX contains undeclared Yellow#5.
Product, lots & distribution
Vista MAX; Dietary Supplement, 90 Capsules. Serving Size: 4 Capsules; Distributed by: Vision of Health, Bell, CA 90201 UPC: PHF-C023 — Distribution: Product was distributed to two local direct accounts. Both are local retail stores selling various vitamins and health products. — Lots/codes: Lots: 509011; 506013; 409012; Expiration: 09/27; 06/27; 09/26 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 17, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries,…
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Product, lots & distribution
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6 — Distribution: Nationwide in the USA — Lots/codes: Lot AE01763, Expires 9/30/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 16, 2026
The Harvard Drug Group LLC: Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 4626…
Subpotent Drug
Product, lots & distribution
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10. — Distribution: U.S. Nationwide. — Lots/codes: Lots: N02327, expires: 09/2026; N02740, expires: 12/2026; N03069, expires: 08/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 12, 2026
Par Health USA, LLC: Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355…
Crystallization; identified as Buprenorphine free base
Product, lots & distribution
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05 — Distribution: Nationwide in the USA. — Lots/codes: Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 12, 2026
Boehringer Ingelheim Pharmaceuticals, Inc.: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boe…
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Product, lots & distribution
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45 — Distribution: OH — Lots/codes: Lot 3244413; Exp. 12/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 7…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: 4298581, expires: 09/30/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b)…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: (a) 3214024, 3199359, 3200136, Exp 6/30/2026, 3212372, Exp. 7/31/2026, 3237018, 3243267, 3264290, Exp. 8/31/2026, 3313291, Exp. 10/31/2026, 3334121, Exp. 11/30/2026, 4030693, 4033380, Exp 1/31/2027, 4058103, 4065931, Exp. 2/28/2027, 4093245, 4094302, Exp. 3/31/2027, 4145548, 4146564, Exp. 5/31/2027, 4191049, Exp 6/30/2027, 4214794, 4218807, Exp. 7/31/2027, 4249036, Exp. 8/31/2027, 4254217, 4330005, 4277387, 4275877, 4276225, 4276231, Exp. 9/30/2027, 4304554, 4304577, 4305852, Exp. 10/31/2027, 4332555, Exp. 11/30/2027, 4348701, 4366429, Exp. 12/31/2027, 5016607, 5016609, 5017377, 5018775,… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, s…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS:…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: a) 3194046, Exp. 06/30/2026, 3217036, Exp 07/31/2026, 3279434, Exp 09/30/2026, 3286268, 3304460, Exp 10/31/2026, 3346277, Exp 11/30/2026, 4031686, 4039656, Exp 01/31/2027, 4048949, 4060437, 4067207, Exp 02/28/2027, 4092773, 4094978, 4106623, Exp 03/31/2027, 4120371, 4129596, Exp 04/30/2027, 4144918, Exp 05/31/2027, 4193623 4200771, Exp 06/30/2027, 4227747, 4250845, Exp 08/31/2027, 50872610, 5093809, Exp 03/31/2028, 5121323, Exp 04/30/2028. b) 3331331, Exp 11/30/2026, 4284935, Exp 10/31/2027, 4344682, Exp 11/30/2027, 5015852, Exp 01/31/2028, 5086227, Exp 03/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 9…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: a) 3291614, Exp 10/31/2026, 4034080, 4036599, Exp 01/31/2027, 4081350, Exp 03/31/2027, 5008234, Exp 12/31/2027. b) 2320053, Exp 11/30/2025, 4151258, Exp 05/31/2027. 5084224, Exp 03/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: a) 4157798, Exp 05/31/2027, 5016842, Exp 12/31/2027, 5112542, Exp 04/30/2028 b) 3330777, Exp 10/31/2026, 3345111, Exp 12/31/2026, 4037991, Exp 01/31/2027, 4114505, Exp 04/30/2027, 4156664, Exp 05/31/2027, 4270441, Exp 09/30/2027, 5078395, Exp 03/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidi…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: 4088933, Exp 03/31/2027, 4177711, 4195438, Exp 06/30/2027, 5051114, Exp 02/29/2028, 5070540, Exp 03/31/2028, 5106254, Exp 04/30/2028, 5141607, Exp 05/31/2028, 5196494, Exp 07/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subs…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: 4190081, Exp 06/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
BioMed Laboratories, LLC.: Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13…
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Product, lots & distribution
Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04 — Distribution: Nationwide in the US — Lots/codes: Lots 0001882643, 0001887165, 0001888441, 0001900835, 0001931329 & 0001951664 May 2026 Lots 0001882644, 0001899186, 0001903516, 0001905970, 0001911902, 0001917707 & 0001920638 June 2026 Lot 0001927080 Oct 2026 Lots 0001937896, 0001952194 & 0001962232, Jan-2027 Lots 0001981964, 0001981965, 0001994680 & 002012768, May 2027 Lot 0001998027, Jun 2027 Lot 002012787, Aug 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 11, 2026
Wondermade LLC: Alabama Banana Pudding Marshmallow, 4 ounce 16 pieces of individual marshmallows packaged in a sealed plastic bag inside a printed cardboard box
Foreign material: small metal pieces
Product, lots & distribution
Alabama Banana Pudding Marshmallow, 4 ounce 16 pieces of individual marshmallows packaged in a sealed plastic bag inside a printed cardboard box — Distribution: Product was distributed to PA, TX, IN, FL — Lots/codes: Expiration Date: July 28,2026 — Status: Ongoing (voluntary: firm initiated)