Class IIMedicationMay 1, 2026
Safecor Health, LLC: Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by:…
Presence of a Foreign Substance; black particles observed in liquid
Product, lots & distribution
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08 — Distribution: OH — Lots/codes: Lot, expiry: Lots 26110722, 26110743, exp 9/8/2026; Lot 26111218, exp 9/9/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 30, 2026
Safecor Health, LLC: Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Product, lots & distribution
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01 — Distribution: TX only — Lots/codes: Lot #: 25530722 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 29, 2026
Ajanta Pharma Ltd.: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Ph…
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Product, lots & distribution
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India — Distribution: Nationwide within U.S — Lots/codes: Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 29, 2026
Ajanta Pharma Ltd.: Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Product, lots & distribution
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03 — Distribution: Nationwide within U.S — Lots/codes: Lot#: PA07434, Exp. May 2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 29, 2026
Ajanta Pharma Ltd.: Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Product, lots & distribution
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06. — Distribution: Nationwide within U.S — Lots/codes: Lot#: PA10734, Exp. Jun 2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 29, 2026
Zydus Pharmaceuticals (USA) Inc: Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (…
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Product, lots & distribution
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1). — Distribution: Nationwide within the U.S — Lots/codes: Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 29, 2026
Zydus Pharmaceuticals (USA) Inc: Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (…
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Product, lots & distribution
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3). — Distribution: Nationwide within the U.S — Lots/codes: Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027. — Status: Ongoing (voluntary: firm initiated)
Class IMedicationApr 28, 2026
B BRAUN MEDICAL INC: Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Presence of Particulate Matter.
Product, lots & distribution
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #:J4P756, J4S843, Exp 5/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 27, 2026
Oasis Medical, Inc.: Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made…
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Product, lots & distribution
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1. — Distribution: Nationwide within the United States — Lots/codes: Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 27, 2026
Golden State Medical Supply Inc.: Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-…
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05 — Distribution: USA Nationwide — Lots/codes: Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 27, 2026
Golden State Medical Supply Inc.: Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-63…
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01 — Distribution: USA Nationwide — Lots/codes: Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 27, 2026
Ascend Laboratories, LLC: Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laborat…
Failed Dissolution Specifications
Product, lots & distribution
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01. — Distribution: U.S. Nationwide — Lots/codes: Lot # 25140859; Exp. Date: Jan 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 24, 2026
Teva Pharmaceuticals USA, Inc: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe co…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Product, lots & distribution
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21. — Distribution: Nationwide in the USA — Lots/codes: Lot: 45011002, Exp. 03/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 24, 2026
Lannett Company Inc.: Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. — Distribution: USA Nationwide — Lots/codes: Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 24, 2026
Lupin Pharmaceuticals Inc.: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA…
Presence of particulate matter: a white thread-like structure in the cartridge
Product, lots & distribution
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03. — Distribution: Nationwide within U.S — Lots/codes: Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2027; WB00104, WB00106, WB00105, Expires: Oct. 2027. — Status: Ongoing (voluntary: firm initiated)
Class IMedicationApr 24, 2026
Wisconsin Pharmacal Company: MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 5…
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Product, lots & distribution
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037. — Distribution: USA Nationwide and Bahamas — Lots/codes: Lot #: 1024088, Exp 11/30/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 23, 2026
Thea Pharma, Inc.: iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Product, lots & distribution
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11 — Distribution: Nationwide within the United States — Lots/codes: Lot#: 3T36B, Exp. Date October 31, 2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 23, 2026
Thea Pharma, Inc.: Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Product, lots & distribution
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11 — Distribution: Nationwide within the United States — Lots/codes: Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 23, 2026
JB Chemicals and Pharmaceuticals Ltd: Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceutica…
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Product, lots & distribution
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10. — Distribution: Nationwide in the USA — Lots/codes: Lot #: GEH25023, Expires: 6/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 22, 2026
CareFusion 213, LLC: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 7…
Lack of assurance of Sterility: potential product contamination
Product, lots & distribution
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42. — Distribution: Nationwide in the USA — Lots/codes: Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 22, 2026
CareFusion 213, LLC: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213,…
Lack of assurance of Sterility: potential product contamination
Product, lots & distribution
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41 — Distribution: Nationwide in the USA — Lots/codes: Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 21, 2026
Alcon Research LLC: Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Product, lots & distribution
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01 — Distribution: Nationwide within the United States — Lots/codes: Lot#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027; Lot# 1W39, 1W40, Exp Date: 3/31/2027; Lot# 1X76, Exp Date: 4/30/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 21, 2026
Alcon Research LLC: GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Product, lots & distribution
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 21, 2026
Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Brecken…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Product, lots & distribution
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90. — Distribution: Nationwide in the USA — Lots/codes: Lot: 241069C, Exp 05/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 20, 2026
SCOPE HEALTH: Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.
Lack of Assurance of Sterility
Product, lots & distribution
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01. — Distribution: Nationwide within the United States — Lots/codes: Lot#: 8T98, 9T31, 9T32, Exp. Date: 30/04/26; 2V13, 2V14, 2V15, Exp. Date 30/06/26; 3V35, Exp. Date 31/08/26;3V36, 3V37, Exp. Date 30/09/26; 5V45, 5V46, 9V12, Exp. Date 31/03/27; 1X57, 1X70, 1X84, Exp. Date 31/05/27. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 20, 2026
Acella Pharmaceuticals, LLC: NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-…
Chemical contamination; presence of lead and lithium above specification
Product, lots & distribution
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16 — Distribution: Nationwide — Lots/codes: Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 17, 2026
Harrow Eye LLC: FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Lack of Assurance of Sterility
Product, lots & distribution
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 1X68, 1X69, Exp. Date 05/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 16, 2026
American Regent, Inc.: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
Labeling: Missing Label
Product, lots & distribution
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01 — Distribution: U.S. Nationwide — Lots/codes: Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 14, 2026
Premier Dental Products Co: Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-…
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Product, lots & distribution
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 640911253, Exp Date. 09/14/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 13, 2026
Unichem Pharmaceuticals USA Inc.: busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India M…
Subpotent drug
Product, lots & distribution
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05. — Distribution: USA Nationwide — Lots/codes: Lot: ZBUL25001, Exp 12/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 9, 2026
The Harvard Drug Group LLC: Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, In…
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Product, lots & distribution
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06 — Distribution: Nationwide in the USA — Lots/codes: Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Apotex Corp.: Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505…
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Product, lots & distribution
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0 — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: VM4231, Exp 06/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IMedicationApr 8, 2026
Blaine Labs Inc: Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Sprin…
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Product, lots & distribution
Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02. — Distribution: Nationwide in the USA — Lots/codes: Lot#: BL3608, Exp. 07/01/28. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78…
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Product, lots & distribution
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01. — Distribution: Nationwide in the USA — Lots/codes: Lot #: BL3435, Exp. 11/06/26 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product, lots & distribution
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01. — Distribution: Nationwide in the USA — Lots/codes: Lot #BL3411R, Exp 6/8/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product, lots & distribution
TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01. — Distribution: Nationwide in the USA — Lots/codes: Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product, lots & distribution
vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2. — Distribution: Nationwide in the USA — Lots/codes: Lot BL3462, Exp. 2/7/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product, lots & distribution
TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01 — Distribution: Nationwide in the USA — Lots/codes: Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product, lots & distribution
Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc — Distribution: Nationwide in the USA — Lots/codes: Lot BL3572, Exp 04/16/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, w…
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Product, lots & distribution
Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670, — Distribution: Nationwide in the USA — Lots/codes: Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 7, 2026
Water-Jel Technologies, LLC: Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, R…
Failed PH Specifications
Product, lots & distribution
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950 — Distribution: Nationwide in the USA — Lots/codes: Lots: A5014, A5018, A5019 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 7, 2026
Hikma Pharmaceuticals USA INC: Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC…
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Product, lots & distribution
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59. — Distribution: US Nationwide. — Lots/codes: Lot # AC2040A, Exp Date: 04/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 6, 2026
Fresenius Medical Care Holdings, Inc.: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-…
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Product, lots & distribution
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451. — Distribution: Nationwide in the USA — Lots/codes: Lot #: 25CU02007, 25CU02008, 25CU02009 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 6, 2026
Fresenius Medical Care Holdings, Inc.: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-…
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Product, lots & distribution
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451. — Distribution: Nationwide in the USA — Lots/codes: Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 6, 2026
Teva Pharmaceuticals USA, Inc: Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-…
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Product, lots & distribution
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. — Distribution: Nationwide in the USA, Puerto Rico and Virgin Islands — Lots/codes: Lots#: 100067507, 100067508, Exp 07/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 2, 2026
B BRAUN MEDICAL INC: Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Product, lots & distribution
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60. — Distribution: US Nationwide. — Lots/codes: Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 2, 2026
B BRAUN MEDICAL INC: DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Product, lots & distribution
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50. — Distribution: US Nationwide. — Lots/codes: Lot # J5H166, J5H167, Exp Date: 30NOV2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 2, 2026
B BRAUN MEDICAL INC: 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Product, lots & distribution
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60. — Distribution: US Nationwide. — Lots/codes: Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 2, 2026
B BRAUN MEDICAL INC: LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Product, lots & distribution
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60. — Distribution: US Nationwide. — Lots/codes: Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 2, 2026
Huons Co., Ltd.: Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-000…
Lack of Assurance of Sterility
Product, lots & distribution
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton) — Distribution: USA Nationwide. — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)