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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 321–340 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04.

by PAI Holdings LLC

Reason
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Recall initiated
May 15, 2026
Reported by FDA
June 24, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08.

by PAI Holdings LLC

Reason
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Recall initiated
May 15, 2026
Reported by FDA
June 24, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.

by PAI Holdings LLC

Reason
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Recall initiated
May 15, 2026
Reported by FDA
June 24, 2026
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

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

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Recall initiated
May 27, 2026
Reported by FDA
June 24, 2026
Distribution
USA Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass I

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.

by BEEKEEPER'S NATURALS USA INC.

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
June 1, 2026
Reported by FDA
June 17, 2026
Distribution
Nationwide within the United States.

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Drug Recall Ongoing 2026 recordClass II

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.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
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
Recall initiated
May 29, 2026
Reported by FDA
June 17, 2026
Distribution
Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Recall initiated
June 1, 2026
Reported by FDA
June 17, 2026
Distribution
Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass I

Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.

by Haleon US Holdings LLC

Reason
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
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

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.

by Golden State Medical Supply Inc.

Reason
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.
Recall initiated
May 29, 2026
Reported by FDA
June 17, 2026
Distribution
Within the U.S Market.

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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

View recall →

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.

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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 →

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.

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