Class IIIMedicationJun 1, 2026
Sandoz Inc: Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
Labeling: Incorrect or Missing Lot and/or Exp Date
Product, lots & distribution
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31 — Distribution: U.S. Nationwide — Lots/codes: Lot VA0099422; Exp. Date June 30, 2028 — Status: Ongoing (voluntary: firm initiated)
Class IMedicationJun 1, 2026
BEEKEEPER'S NATURALS USA INC.: BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA In…
Microbial Contamination of Non-Sterile Products
Product, lots & distribution
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789. — Distribution: Nationwide within the United States. — Lots/codes: Lot #: 5950, Exp. Date 02/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationJun 1, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-56…
Failed Impurities/Degradation Specifications
Product, lots & distribution
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30 — Distribution: U.S. Nationwide — Lots/codes: Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Golden State Medical Supply Inc.: GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett,…
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Product, lots & distribution
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90. — Distribution: Within the U.S Market. — Lots/codes: Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmac…
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Product, lots & distribution
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49. — Distribution: Nationwide within the United States — Lots/codes: Lot #: BAG0074A, Exp. Date: 1/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3
Subpotent drug
Product, lots & distribution
Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3 — Distribution: Nationwide within the US — Lots/codes: Lot 250306B3, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA
Subpotent drug
Product, lots & distribution
Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA — Distribution: Nationwide within the US — Lots/codes: Lots 250108A2, 250109A1, 250115A1, 250124A1, 250213A1, 250220Z3, 250221A3, 250221A4, 250224A1, 250303A3, 250306A1, 250307A1, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.
Subpotent drug
Product, lots & distribution
Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6. — Distribution: Nationwide within the US — Lots/codes: Lot 250218B3, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924
Subpotent drug
Product, lots & distribution
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924 — Distribution: Nationwide within the US — Lots/codes: Lots 250221A5, 250224A2 within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529
Subpotent drug
Product, lots & distribution
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529 — Distribution: Nationwide within the US — Lots/codes: Lots 250109B1, 250110B1, 250228B1, 250303B1, 250304B1, 250305B1, 250306B1, 250306B2 within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 29, 2026
Gasco Industrial Corp.: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696…
Subpotent drug
Product, lots & distribution
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567. — Distribution: Nationwide within the US — Lots/codes: Lots 250206B1, 250218B2, 250507B1, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 29, 2026
Champion Foods, LLC: Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC 8 70375 00511 1; 6 retail units per case Motor City Pizza Co. 5 Cheese Bread Twin retai…
potential salmonella contamination
Product, lots & distribution
Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC 8 70375 00511 1; 6 retail units per case Motor City Pizza Co. 5 Cheese Bread Twin retail pack; 44.86 oz. (2 lb. 12.9 oz.) 1272g UPC 8 70375 00509 8; 10 retail units per case — Distribution: Affected 5 Cheese Bread lots were distributed and sold nationwide at retailers including Costco, Walmart, Giant Landover, Grocery Outlet, Jewel, Kroger, Schnucks, Target, C&S, Bozzuto s, Brookshire Grocery, Meijer, Food City, KeHe, Lipari,… — Lots/codes: Sell By dates: Single retail pack: 2/4/2027, 2/5/2027, 2/23/2027, 2/24/2027, 3/9/2027, 3/10/2027, 3/17/2027, 3/18/2027, 3/24/2027, 3/25/2027, 4/7/2027, 4/8/2027, 4/20/2027, 4/21/2027 Twin retail pack: 2/3/2027, 2/4/2027, 2/24/2027, 2/25/2027, 3/10/2027, 3/11/2027, 3/18/2027, 3/25/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR:…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027, NDC 63981-171-80 — Distribution: U.S.A. Nationwide — Lots/codes: Lot#: 1716059, 1716060, 1716061, 1716062, 1716063, 1716218, 1716219, 1716228, 1716229, 1716238, Exp 2/28/2029; 1716258, Exp 3/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1096075, 1096076, 1096077, 1096078, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1076169, Exp 2/28/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 1…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-106-80. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428,…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-595-23. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: 24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276119, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, 1276119, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716259, Exp 3/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA.…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., NDC 55319-171-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA.…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., UP: 0 32251-92282-4. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716259, expires: MAR 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276119, expires: Jan 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC 37808-136-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276119, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Ajanta Pharma USA Inc: Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120…
CGMP Deviations
Product, lots & distribution
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04. — Distribution: U.S. Nationwide — Lots/codes: Lot # PA02216; Exp. 12/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
CareFusion 213, LLC: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, T…
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Product, lots & distribution
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 3201277, Exp Date: 06/30/2026; Lot # 3213912, 3214206, 3214914, 3215710, 3227485, Exp Date: 07/31/2026; Lot # 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318, Exp Date: 08/31/2026; Lot # 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956, Exp Date: 09/30/2026; Lot # 3299094, 3299684, 3302529, 3301463, 3309836, 3310556, 3312230, 3314562, Exp Date: 10/31/2026; Lot # 3321426, Exp Date: 11/30/2026; Lot # 3350974, 3352268, 3354120, 3354127, 3356911, 4003299, 4013168, Exp Date: 12/31/2026; Lot # 4023898, 4024208, 4024754, 4030686, 4031689, 4032182, 4032183, 4… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
CareFusion 213, LLC: BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El…
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Product, lots & distribution
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919, 3167620, 3191056, Exp Date: 05/31/2026; Lot # 3171115, 3172853, 3177820, 3193968, 3194750, 3199123, 3201195, 3206618, 3212202, 3213819, 3214876, Exp Date: 06/30/2026; Lot # 3222170, 3226846, 3228153, 3229867, 3228293, 3243337, Exp Date: 07/31/2026; Lot # 3230424, 3234042, 3240990, 3244469, 3249346, 3251278, 3254346, 3255678, 3258407, Exp Date: 08/31/2026; Lot # 3261058, 3263492, 3264573, 3268341, 3270418, 3275533, 3276460, 3278683, 3283037, 3284107, 3292960, 3292965, Exp Date: 09/30/2026; Lot # 3286221, 3290240, 329… — Status: Ongoing (voluntary: firm initiated)
Class IMedicationMay 28, 2026
CareFusion 213, LLC: BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 21…
Non-Sterility: Due to presence of Aspergillus penicillioides.
Product, lots & distribution
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 4032183, Exp 01/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IMedicationMay 28, 2026
CareFusion 213, LLC: BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El…
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Product, lots & distribution
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 4073005, Exp 03/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IFoodMay 28, 2026
Azuma Foods International Inc USA: azuma foods TAKO WASABI Seasoned Octopus with Wasabi PERISHABLE/KEEP FROZEN PRODUCT OF JAPAN DISTRIBUTED BY: AZUMA FOODS INTERNATIONAL INC., U.S.A. HAYWARD, CA 9454…
Undeclared fish.
Product, lots & distribution
azuma foods TAKO WASABI Seasoned Octopus with Wasabi PERISHABLE/KEEP FROZEN PRODUCT OF JAPAN DISTRIBUTED BY: AZUMA FOODS INTERNATIONAL INC., U.S.A. HAYWARD, CA 94545 Retail: 3-50g PACKS NET WT. 5.3 OZ (150g) UPC: 745329900647 Foodservice: 2.2lbs UPC: 745329900746 — Distribution: Domestic: AK, AZ, CA, CO, FL, GA, HI, IL, MD, MA, NC, NJ, NV, NY, OR, TX, WA — Lots/codes: Retail - lot code, best by date: 1CFFDA2, 11/20/2026; 1CFGCH2, 12/18/2026; 1CFIBC2, 2/2/2027; 1CFJCG2, 3/19/2027; 1CFKBH2, 4/9/2027; 1CGBAH2, 6/30/2027. Foodservice - lot code, best by date: 1CFFCI2, 11/18/2026; 1CFFCJ2, 11/19/2026; 1CFFCJ2, 11/29/2026; 1CFFDA2, 11/20/2026; 1CFGCA2, 12/11/2026; 1CFGCA2, 12/11/2026; 1CFGCG2, 12/17/2026; 1CFGCH2, 12/18/2026; 1CFHBB2, 1/1/2027; 1CFIBC2, 2/2/2027; 1CFICI2, 2/18/2027; 1CFICJ2, 2/19/2027; 1CFJAF2, 2/26/2026; 1CFJCG2, 3/19/2027; 1CFKBG2, 4/8/2027; 1CFKBH2, 4/9/2027; 1CFKBH2, 4/9/2027; 1CFLAH2, 4/30/2027; 1CFLCJ2, 5/22/2027; 1CGBAH2, 6/30/2027; 1CGBB… — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 28, 2026
Specialty Bakers, LLC: Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1 plastic tray which holds 6 dess…
Undeclared Allergen (Soy)
Product, lots & distribution
Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1 plastic tray which holds 6 desserts shells. Plastic is wrapped around 1 tray. 24 packs/Case. Frozen — Distribution: The adulterated product was distributed to the following states, Pennsylvania. — Lots/codes: Lot Number: 968674 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 28, 2026
Wise Foods Inc: Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case,
The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.
Product, lots & distribution
Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case, — Distribution: The adulterated product was distributed to the following States: NC, VA, PA, NJ, NY, SC, FL — Lots/codes: UPC: 041262288874 Internal production number: 4228887 Lot Codes (expiration date): AUG0326, AUG1026, AUG1726 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 27, 2026
Lannett Company Inc.: Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Product, lots & distribution
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 25282724A, Exp. Date 2027/01 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 27, 2026
Glenmark Pharmaceuticals Inc., USA: Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day re…
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Product, lots & distribution
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29 — Distribution: USA Nationwide. — Lots/codes: Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 27, 2026
Ajanta Pharma USA Inc: Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Product, lots & distribution
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03. — Distribution: U.S. Nationwide — Lots/codes: Lot: PA00805, expires: 01/31/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodMay 27, 2026
Produce Innovations: Roast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhesive label. The label reads in part as "***Lunch Box Kitchen*** Premium Convenience***Tu…
Incorrect Product Label; Roast Beef and Swiss closed face sub sandwich labeled as Turkey and Cheddar closed face sub sandwich
Product, lots & distribution
Roast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhesive label. The label reads in part as "***Lunch Box Kitchen*** Premium Convenience***Turkey & Cheddar Sub***BEST BY 06/14/26 Lot no. 26 134 NET WEIGHT: 6.1oz***KEEP REFRIGERATED*** Produced by: Produce Innovations***1845 Colonial Parkway Norwalk, IA 50211***" — Distribution: Medical facilities and vending distributors located in IL, IA, KS and MO — Lots/codes: Lot code: 26134 — Status: Terminated (voluntary: firm initiated)
Class IIFoodMay 26, 2026
Nutricia North America: functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 00453 3, package UPC 8 57858 00450 2
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
Product, lots & distribution
functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 00453 3, package UPC 8 57858 00450 2 — Distribution: Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,… — Lots/codes: 24 count case with BEST IF USED BY DATES up to and including March 15, 2028 12 count package BEST IF USED BY DATES up to and including October 7, 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 26, 2026
Nutricia North America: functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 OZ (341g) case UPC 8 57858 00445 8,…
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
Product, lots & distribution
functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 OZ (341g) case UPC 8 57858 00445 8, package UPC 8 57858 00447 2 — Distribution: Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,… — Lots/codes: 24 count case with BEST IF USED BY DATES up to and including April 14, 2028 12 count package BEST IF USED BY DATES up to and including February 19, 2028 — Status: Ongoing (voluntary: firm initiated)
Class IFoodMay 24, 2026
MOGO Moringa LLC: MOGO PURE MORINGA OLEIFERA CAPSULES, HERBAL SUPPLEMENT, 180 QUICK RELEASE VEGGIE CAPSULE, 100% PURE, 350 MG PER CAPSULE, SUPPLEMENT FACTS MORINGA POWDER 1050 mg, Ingredients: 100% P…
Product may be contaminated with Salmonella Typhimurium
Product, lots & distribution
MOGO PURE MORINGA OLEIFERA CAPSULES, HERBAL SUPPLEMENT, 180 QUICK RELEASE VEGGIE CAPSULE, 100% PURE, 350 MG PER CAPSULE, SUPPLEMENT FACTS MORINGA POWDER 1050 mg, Ingredients: 100% Pure Moringa Leaf Powder (Moringa Oleifera), MANUFACTURED IN USA AND Marketed by: MOGO MIRINGA LLC, PO BOX 32066 Saint Louis, MO 63132 — Distribution: Products were sold nationwide via ecommerce (Amazon, Ebay, Etsy, and mogomiranga.com) — Lots/codes: Lot codes: 15525AA exp date: 6/2027 00926AA exp date: 1/2028 — Status: Ongoing (voluntary: firm initiated)