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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 81–100 of 17,898 drug recalls

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

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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 →

Drug Recall Ongoing 2026 recordClass II

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

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

Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.

by QuVa Pharma, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
June 24, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04

by BioMed Laboratories, LLC.

Reason
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Recall initiated
June 11, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide in the US

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Drug Recall Ongoing 2026 recordClass II

Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31

by ONESOURCE SPECIALTY PHARMA LIMITED

Reason
Failed Impurities/Degradation Specifications
Recall initiated
June 7, 2026
Reported by FDA
July 15, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01

by Lupin Pharmaceuticals Inc.

Reason
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Recall initiated
June 23, 2026
Reported by FDA
July 8, 2026
Distribution
Nationwide within the U.S.

View recall →

Drug Recall Ongoing 2026 recordClass II

Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01

by McKesson

Reason
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Recall initiated
June 10, 2026
Reported by FDA
July 8, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,

by Blaine Labs Inc

Reason
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Recall initiated
April 8, 2026
Reported by FDA
July 8, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc

by Blaine Labs Inc

Reason
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Recall initiated
April 8, 2026
Reported by FDA
July 8, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01

by Blaine Labs Inc

Reason
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Recall initiated
April 8, 2026
Reported by FDA
July 8, 2026
Distribution
Nationwide in the USA

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.