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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 921–940 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass III

Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01

by Qualgen, LLC

Reason
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Recall initiated
June 16, 2025
Reported by FDA
July 23, 2025
Distribution
Nationwide within the United States.

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Drug Recall Ongoing Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Recall initiated
June 16, 2025
Reported by FDA
July 23, 2025
Distribution
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.

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Drug Recall Ongoing Historical recordClass II

In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL - 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1

by KABANA SKIN CARE

Reason
cGMP deviations
Recall initiated
March 12, 2025
Reported by FDA
July 16, 2025
Distribution
NJ, FL, MI

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Drug Recall Ongoing Historical recordClass II

GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1

by KABANA SKIN CARE

Reason
cGMP deviations
Recall initiated
March 12, 2025
Reported by FDA
July 16, 2025
Distribution
NJ, FL, MI

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Drug Recall Ongoing Historical recordClass II

Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1

by KABANA SKIN CARE

Reason
cGMP deviations
Recall initiated
March 12, 2025
Reported by FDA
July 16, 2025
Distribution
NJ, FL, MI

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Drug Recall Ongoing Historical recordClass II

B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2.

by KABANA SKIN CARE

Reason
cGMP deviations
Recall initiated
March 12, 2025
Reported by FDA
July 16, 2025
Distribution
NJ, FL, MI

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated
June 30, 2025
Reported by FDA
July 16, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass III

Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.

by Macleods Pharmaceuticals Ltd

Reason
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Recall initiated
June 11, 2025
Reported by FDA
July 16, 2025
Distribution
U.S. Nationwide.

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Drug Recall Ongoing Historical recordClass I

Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.

by Sandoz Inc

Reason
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Recall initiated
June 27, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).

by Sandoz Inc

Reason
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Recall initiated
June 27, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90

by AvKARE

Reason
Failed Impurity/Degradation Specifications
Recall initiated
June 26, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

by AvKARE

Reason
Failed Impurity/Degradation Specifications
Recall initiated
June 26, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98.

by Orient Pharma Co., Ltd. Yunlin Plant

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
June 11, 2025
Reported by FDA
July 9, 2025
Distribution
NJ

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Drug Recall Ongoing Historical recordClass III

Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98.

by Orient Pharma Co., Ltd. Yunlin Plant

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
June 11, 2025
Reported by FDA
July 9, 2025
Distribution
NJ

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Drug Recall Ongoing Historical recordClass II

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,

by Granules Pharmaceuticals Inc.

Reason
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Recall initiated
June 24, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0

by The Harvard Drug Group LLC

Reason
Defective container; blister packaging inadequately sealed.
Recall initiated
June 19, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61

by The Harvard Drug Group LLC

Reason
Defective container; blister packaging inadequately sealed.
Recall initiated
June 19, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.

by Church & Dwight Inc

Reason
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Recall initiated
June 6, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass I

ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6

by Church & Dwight Inc

Reason
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Recall initiated
June 6, 2025
Reported by FDA
July 9, 2025
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass I

ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5

by Church & Dwight Inc

Reason
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Recall initiated
June 6, 2025
Reported by FDA
July 9, 2025
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.