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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 1,061–1,080 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00

by RemedyRePack Inc.

Reason
CGMP Deviations
Recall initiated
March 24, 2025
Reported by FDA
April 30, 2025
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Recall initiated
April 10, 2025
Reported by FDA
April 30, 2025
Distribution
USA nationwide

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Drug Recall Ongoing Historical recordClass II

Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363

by Apipharma

Reason
CGMP Deviations
Recall initiated
April 9, 2025
Reported by FDA
April 30, 2025
Distribution
AZ

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Drug Recall Ongoing Historical recordClass II

Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11

by Denver Solutions, LLC DBA Leiters Health

Reason
Lack of Assurance of Sterility: Leaking/damaged syringes.
Recall initiated
March 31, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the U.S.A

View recall →

Drug Recall Ongoing Historical recordClass II

PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,

by Denver Solutions, LLC DBA Leiters Health

Reason
Lack of Assurance of Sterility: Leaking/damaged syringes.
Recall initiated
March 31, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the U.S.A

View recall →

Drug Recall Ongoing Historical recordClass II

dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.

by Denver Solutions, LLC DBA Leiters Health

Reason
Lack of Assurance of Sterility: Leaking/damaged syringes.
Recall initiated
March 31, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the U.S.A

View recall →

Drug Recall Ongoing Historical recordClass II

Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11

by Denver Solutions, LLC DBA Leiters Health

Reason
Lack of Assurance of Sterility: Leaking/damaged syringes.
Recall initiated
March 31, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the U.S.A

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiated
April 14, 2025
Reported by FDA
April 30, 2025
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiated
April 14, 2025
Reported by FDA
April 30, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY

by Medisca Inc.

Reason
CGMP Deviations
Recall initiated
March 31, 2025
Reported by FDA
April 30, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30

by Pharmadel, LLC

Reason
cGMP deviations
Recall initiated
April 15, 2025
Reported by FDA
April 30, 2025
Distribution
DE

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Drug Recall Terminated Historical recordClass II

Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15

by Pharmadel, LLC

Reason
cGMP deviations
Recall initiated
April 15, 2025
Reported by FDA
April 30, 2025
Distribution
DE

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Drug Recall Terminated Historical recordClass II

DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15

by Pharmadel, LLC

Reason
cGMP deviations
Recall initiated
April 15, 2025
Reported by FDA
April 30, 2025
Distribution
DE

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Drug Recall Ongoing Historical recordClass II

Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318

by Apipharma

Reason
CGMP Deviations
Recall initiated
April 9, 2025
Reported by FDA
April 30, 2025
Distribution
AZ

View recall →

Drug Recall Ongoing Historical recordClass II

Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11

by Denver Solutions, LLC DBA Leiters Health

Reason
Lack of Assurance of Sterility: Leaking/damaged syringes.
Recall initiated
March 31, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the U.S.A

View recall →

Drug Recall Ongoing Historical recordClass II

Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.

by Amerisource Health Services LLC

Reason
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recall initiated
April 2, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.

by Amerisource Health Services LLC

Reason
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recall initiated
April 2, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.

by Amerisource Health Services LLC

Reason
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recall initiated
April 2, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Recall initiated
April 14, 2025
Reported by FDA
April 23, 2025
Distribution
Nationwide USA

View recall →

Drug Recall Ongoing Historical recordClass I

Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52

by Dr. Reddy's Laboratories, Inc.

Reason
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Recall initiated
March 13, 2025
Reported by FDA
April 23, 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.