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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 61–80 of 17,898 drug recalls

Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61

by MAJOR PHARMACEUTICALS

Reason
Subpotent Drug
Recall initiated
July 13, 2026
Reported by FDA
July 29, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61

by MAJOR PHARMACEUTICALS

Reason
Subpotent Drug
Recall initiated
July 13, 2026
Reported by FDA
July 29, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61

by MAJOR PHARMACEUTICALS

Reason
Subpotent Drug
Recall initiated
July 13, 2026
Reported by FDA
July 29, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61

by MAJOR PHARMACEUTICALS

Reason
Subpotent Drug
Recall initiated
July 13, 2026
Reported by FDA
July 29, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61

by MAJOR PHARMACEUTICALS

Reason
Subpotent Drug
Recall initiated
July 13, 2026
Reported by FDA
July 29, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61

by MAJOR PHARMACEUTICALS

Reason
Subpotent Drug
Recall initiated
July 13, 2026
Reported by FDA
July 29, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61

by MAJOR PHARMACEUTICALS

Reason
Subpotent Drug
Recall initiated
July 13, 2026
Reported by FDA
July 29, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31

by CareFusion 213, LLC

Reason
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Recall initiated
July 9, 2026
Reported by FDA
July 22, 2026
Distribution
U.S.A. Nationwide

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Drug Recall Ongoing 2026 recordClass II

CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.

by Chiesi USA, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 6, 2026
Reported by FDA
July 22, 2026
Distribution
Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.

by Bell Pharmaceuticals, Inc

Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Recall initiated
June 25, 2026
Reported by FDA
July 22, 2026
Distribution
U.S Nationwide

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Drug Recall Ongoing 2026 recordClass II

meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

by Bell Pharmaceuticals, Inc

Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Recall initiated
June 25, 2026
Reported by FDA
July 22, 2026
Distribution
U.S Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.

by Bell Pharmaceuticals, Inc

Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Recall initiated
June 25, 2026
Reported by FDA
July 22, 2026
Distribution
U.S Nationwide

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Drug Recall Ongoing 2026 recordClass II

LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.

by Bell Pharmaceuticals, Inc

Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Recall initiated
June 25, 2026
Reported by FDA
July 22, 2026
Distribution
U.S Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.

by Bell Pharmaceuticals, Inc

Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Recall initiated
June 25, 2026
Reported by FDA
July 22, 2026
Distribution
U.S Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.

by Bell Pharmaceuticals, Inc

Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Recall initiated
June 25, 2026
Reported by FDA
July 22, 2026
Distribution
U.S Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.

by Bell Pharmaceuticals, Inc

Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Recall initiated
June 25, 2026
Reported by FDA
July 22, 2026
Distribution
U.S Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.

by Bell Pharmaceuticals, Inc

Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Recall initiated
June 25, 2026
Reported by FDA
July 22, 2026
Distribution
U.S Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.

by Bell Pharmaceuticals, Inc

Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Recall initiated
June 25, 2026
Reported by FDA
July 22, 2026
Distribution
U.S Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.

by Bell Pharmaceuticals, Inc

Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Recall initiated
June 25, 2026
Reported by FDA
July 22, 2026
Distribution
U.S Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,

by Bell Pharmaceuticals, Inc

Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Recall initiated
June 25, 2026
Reported by FDA
July 22, 2026
Distribution
U.S 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.