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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 221–240 of 18,047 drug recalls

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

View recall →

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 →

Drug Recall Ongoing 2026 recordClass II

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35

by Padagis US LLC

Reason
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Recall initiated
June 23, 2026
Reported by FDA
July 22, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.

by Shimoga Chemicals

Reason
cGMP deviations
Recall initiated
May 19, 2026
Reported by FDA
July 15, 2026
Distribution
CA & FL only

View recall →

Drug Recall Ongoing 2026 recordClass II

Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01

by Reliance Life Sciences Private Limited

Reason
Lack of Sterility Assurance
Recall initiated
June 24, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01

by Reliance Life Sciences Private Limited

Reason
Lack of Sterility Assurance
Recall initiated
June 24, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01

by Reliance Life Sciences Private Limited

Reason
Lack of Sterility Assurance
Recall initiated
June 24, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01

by Reliance Life Sciences Private Limited

Reason
Lack of Sterility Assurance
Recall initiated
June 24, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

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.

by Gasco Industrial Corp.

Reason
Subpotent drug
Recall initiated
May 29, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide within the US

View recall →

Drug Recall Ongoing 2026 recordClass II

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

by Gasco Industrial Corp.

Reason
Subpotent drug
Recall initiated
May 29, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide within the US

View recall →

Drug Recall Ongoing 2026 recordClass II

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

by Gasco Industrial Corp.

Reason
Subpotent drug
Recall initiated
May 29, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide within the US

View recall →

Drug Recall Ongoing 2026 recordClass II

Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.

by Gasco Industrial Corp.

Reason
Subpotent drug
Recall initiated
May 29, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide within the US

View recall →

Drug Recall Ongoing 2026 recordClass II

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

by Gasco Industrial Corp.

Reason
Subpotent drug
Recall initiated
May 29, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide within the US

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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