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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 1,201–1,220 of 17,937 drug recalls

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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Drug Recall Ongoing Historical recordClass II

Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1

by Denison Pharmaceuticals, LLC

Reason
Chemical Contamination: Presence of benzene.
Recall initiated
February 24, 2025
Reported by FDA
March 19, 2025
Distribution
Nationwide within the USA

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Drug Recall Ongoing Historical recordClass I

PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Presence of Particulate Matter
Recall initiated
February 20, 2025
Reported by FDA
March 19, 2025
Distribution
Product was distributed nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated
February 28, 2025
Reported by FDA
March 19, 2025
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated
February 28, 2025
Reported by FDA
March 19, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated
February 28, 2025
Reported by FDA
March 19, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269

by ICU Medical, Inc.

Reason
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Recall initiated
February 13, 2025
Reported by FDA
March 19, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267

by ICU Medical, Inc.

Reason
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Recall initiated
February 13, 2025
Reported by FDA
March 19, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0

by Chattem Inc

Reason
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Recall initiated
March 4, 2025
Reported by FDA
March 19, 2025
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.

by Aspen Biopharma Labs Pvt., Ltd.

Reason
CGMP Deviations
Recall initiated
February 7, 2025
Reported by FDA
March 19, 2025
Distribution
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

View recall →

Drug Recall Ongoing Historical recordClass II

Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle

by Aspen Biopharma Labs Pvt., Ltd.

Reason
CGMP Deviations
Recall initiated
February 7, 2025
Reported by FDA
March 19, 2025
Distribution
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

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.