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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 281–300 of 17,898 drug recalls

Drug Recall Ongoing 2026 recordClass II

Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0

by Apotex Corp.

Reason
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Recall initiated
April 8, 2026
Reported by FDA
April 22, 2026
Distribution
U.S.A. Nationwide

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Drug Recall Ongoing 2026 recordClass III

Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1

by Avantor Performance Materials LLC

Reason
Subpotent drug
Recall initiated
March 31, 2026
Reported by FDA
April 22, 2026
Distribution
Nationwide in the USA, Belgium and France

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Drug Recall Ongoing 2026 recordClass II

Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.

by Island Kinetics, Inc. d.b.a. CoValence Laboratories

Reason
Failed Stability Specifications
Recall initiated
April 1, 2026
Reported by FDA
April 22, 2026
Distribution
U.S. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61

by The Harvard Drug Group LLC

Reason
Failed Dissolution Specifications
Recall initiated
March 24, 2026
Reported by FDA
April 22, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1

by International Medication Systems Ltd.

Reason
Lack of Assurance of Sterility
Recall initiated
April 1, 2026
Reported by FDA
April 22, 2026
Distribution
U.S. Nationwide

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Drug Recall Terminated 2026 recordClass III

Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05

by Island Kinetics, Inc. d.b.a. CoValence Laboratories

Reason
Subpotent Drug
Recall initiated
March 18, 2026
Reported by FDA
April 22, 2026
Distribution
U.S. Nationwide

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Drug Recall Terminated 2026 recordClass III

Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04

by Island Kinetics, Inc. d.b.a. CoValence Laboratories

Reason
Subpotent Drug
Recall initiated
March 18, 2026
Reported by FDA
April 22, 2026
Distribution
U.S. Nationwide

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Drug Recall Terminated 2026 recordClass III

Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13

by Island Kinetics, Inc. d.b.a. CoValence Laboratories

Reason
Subpotent Drug
Recall initiated
March 18, 2026
Reported by FDA
April 22, 2026
Distribution
U.S. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.

by Nephron SC, LLC

Reason
Labelling: Illegible label
Recall initiated
March 17, 2026
Reported by FDA
April 22, 2026
Distribution
Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Recall initiated
March 25, 2026
Reported by FDA
April 22, 2026
Distribution
Nationwide in the USA.

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Drug Recall Ongoing 2026 recordClass II

Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Recall initiated
March 25, 2026
Reported by FDA
April 22, 2026
Distribution
Nationwide in the USA.

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Drug Recall Ongoing 2026 recordClass II

Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Recall initiated
March 25, 2026
Reported by FDA
April 22, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR

by PAYLESS COMPOUNDERS, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 6, 2026
Reported by FDA
April 22, 2026
Distribution
OR

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Drug Recall Ongoing 2026 recordClass II

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411.

by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Reason
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Recall initiated
March 20, 2026
Reported by FDA
April 22, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718.

by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Reason
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Recall initiated
March 20, 2026
Reported by FDA
April 22, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-617-30, UPC: 63551598673.

by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Reason
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Recall initiated
March 20, 2026
Reported by FDA
April 22, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-625-30, UPC: 635515999398.

by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Reason
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Recall initiated
March 20, 2026
Reported by FDA
April 22, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.

by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Reason
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Recall initiated
March 20, 2026
Reported by FDA
April 22, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.

by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Reason
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Recall initiated
March 20, 2026
Reported by FDA
April 22, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.

by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Reason
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Recall initiated
March 20, 2026
Reported by FDA
April 22, 2026
Distribution
US 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.