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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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Drug Recall Ongoing Historical recordClass II

Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02

by Strides Pharma, Inc.

Reason: Presence of foreign substance: Presence of Benzene.
Recall initiated: March 5, 2025
Reported by FDA: April 2, 2025
Distribution: Nationwide in the U.S

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Drug Recall Ongoing Historical recordClass II

METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.

by A-S Medication Solutions LLC

Reason: Presence of Foreign Tablets/Capsules.
Recall initiated: February 25, 2025
Reported by FDA: April 2, 2025
Distribution: Nationwide in U.S.

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.

by Mylan Institutional, Inc.

Reason: Super-Potent Drug: Out of specification potency results were obtained.
Recall initiated: March 7, 2025
Reported by FDA: March 26, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.

by Mylan Institutional, Inc.

Reason: Super-Potent Drug: Out of specification potency results were obtained.
Recall initiated: March 7, 2025
Reported by FDA: March 26, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.

by MEDLINE INDUSTRIES, LP - Northfield

Reason: Subpotent Drug
Recall initiated: February 17, 2025
Reported by FDA: March 26, 2025
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.

by MEDLINE INDUSTRIES, LP - Northfield

Reason: Subpotent Drug
Recall initiated: February 17, 2025
Reported by FDA: March 26, 2025
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30

by Golden State Medical Supply Inc.

Reason: Failed Dissolution Specifications
Recall initiated: March 5, 2025
Reported by FDA: March 26, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box).

by Amgen, Inc.

Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Recall initiated: February 27, 2025
Reported by FDA: March 26, 2025
Distribution: Nationwide in the U.S.A. and Belgium/Luxembourg, Brazil, Chile, Colombia, France/French Guiana, Germany, Ireland, Italy/San Marino, Netherlands, Poland, Spain/Andorra, Sweden, Finland, Switzerland/Liechtenstein, United Kingdom of Great Britain and Northern Ireland, Ireland, Denmark, Canada, Hong Kong, Philippines, Israel, Malaysia, Saudi Arabia, Gibraltar.

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Drug Recall Ongoing Historical recordClass II

Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box).

by Amgen, Inc.

Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Recall initiated: February 27, 2025
Reported by FDA: March 26, 2025
Distribution: Nationwide in the U.S.A. and Belgium/Luxembourg, Brazil, Chile, Colombia, France/French Guiana, Germany, Ireland, Italy/San Marino, Netherlands, Poland, Spain/Andorra, Sweden, Finland, Switzerland/Liechtenstein, United Kingdom of Great Britain and Northern Ireland, Ireland, Denmark, Canada, Hong Kong, Philippines, Israel, Malaysia, Saudi Arabia, Gibraltar.

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Drug Recall Ongoing Historical recordClass II

CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc

by Fruit Of The Earth, Inc.

Reason: Chemical contamination: presence of benzene
Recall initiated: March 11, 2025
Reported by FDA: March 26, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015

by Fruit Of The Earth, Inc.

Reason: Chemical contamination: presence of benzene
Recall initiated: March 11, 2025
Reported by FDA: March 26, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05

by FDC Limited

Reason: Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Recall initiated: March 11, 2025
Reported by FDA: March 26, 2025
Distribution: Nationwide in the U.S

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Drug Recall Ongoing Historical recordClass I

Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.

by One Source Nutrition, Inc,

Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Recall initiated: February 20, 2025
Reported by FDA: March 26, 2025
Distribution: Nationwide in the U.S.A

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Drug Recall Ongoing Historical recordClass II

Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93

by MYLAN PHARMACEUTICALS INC

Reason: Failed Dissolution Specifications - low dissolution results
Recall initiated: February 25, 2025
Reported by FDA: March 26, 2025
Distribution: US Nationwide.

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Drug Recall Completed Historical recordClass II

Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04

by Slate Run Pharmaceuticals

Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Recall initiated: March 7, 2025
Reported by FDA: March 26, 2025
Distribution: Product was distributed to 8 distributors who may have further distribute the product nationwide.

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Drug Recall Completed Historical recordClass II

Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04

by Slate Run Pharmaceuticals

Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Recall initiated: March 7, 2025
Reported by FDA: March 26, 2025
Distribution: Product was distributed to 8 distributors who may have further distribute the product nationwide.

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99

by Rising Pharma Holding, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recall initiated: March 5, 2025
Reported by FDA: March 26, 2025
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916

by Johnson, S C and Son, Inc

Reason: Chemical Contamination
Recall initiated: February 13, 2025
Reported by FDA: March 19, 2025
Distribution: Nationwide within the United States and Canada

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Drug Recall Ongoing Historical recordClass II

Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403.

by Johnson, S C and Son, Inc

Reason: Chemical Contamination
Recall initiated: February 13, 2025
Reported by FDA: March 19, 2025
Distribution: Nationwide within the United States and Canada

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Drug Recall Ongoing Historical recordClass II

Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8

by Sigan Industries Group Inc.

Reason: Chemical Contamination: Presence of benzene
Recall initiated: February 28, 2025
Reported by FDA: March 19, 2025
Distribution: Nationwide in the U.S.A

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Data last updated: October 31, 2026 ET

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.