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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 181–200 of 17,898 drug recalls

Drug Recall Ongoing 2026 recordClass II

Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.

by Zep Inc

Reason
Microbial contamination of sterile products
Recall initiated
May 22, 2026
Reported by FDA
June 17, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass III

Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01

by Amneal Pharmaceuticals, LLC

Reason
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Recall initiated
June 3, 2026
Reported by FDA
June 17, 2026
Distribution
Nationwide within the USA.

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Drug Recall Ongoing 2026 recordClass II

Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated
June 4, 2026
Reported by FDA
June 17, 2026
Distribution
Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated
June 4, 2026
Reported by FDA
June 17, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass III

Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)

by Fresenius Kabi USA, LLC

Reason
Failed Impurities/Degradations Specifications
Recall initiated
May 14, 2026
Reported by FDA
June 17, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass I

DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence of Particulate matter: Particulate matter identified as glass.
Recall initiated
May 12, 2026
Reported by FDA
June 17, 2026
Distribution
U.S. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Recall initiated
May 22, 2026
Reported by FDA
June 10, 2026
Distribution
Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Recall initiated
May 22, 2026
Reported by FDA
June 10, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

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.

by Lannett Company Inc.

Reason
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Recall initiated
May 27, 2026
Reported by FDA
June 10, 2026
Distribution
Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

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.

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

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Drug Recall Ongoing 2026 recordClass II

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.

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

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.

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

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.

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

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.

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

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.

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

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.

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

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.

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

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.

by Guardian Drug Co. Inc.

Reason
Presence of foreign substance: small metallic particles in chewable tablets.
Recall initiated
May 28, 2026
Reported by FDA
June 10, 2026
Distribution
U.S.A. Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.