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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 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.

by Cardinal Health Inc.

Reason
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Recall initiated
April 9, 2025
Reported by FDA
May 7, 2025
Distribution
NC, SC, VA

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Drug Recall Ongoing Historical recordClass II

Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial).

by Nubratori, Inc

Reason
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Recall initiated
April 15, 2025
Reported by FDA
May 7, 2025
Distribution
PA and CA.

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Drug Recall Ongoing Historical recordClass II

Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.

by Preferred Pharmaceuticals, Inc.

Reason
cGMP Deviations
Recall initiated
April 18, 2025
Reported by FDA
May 7, 2025
Distribution
Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01

by Eugia US LLC

Reason
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Recall initiated
April 21, 2025
Reported by FDA
May 7, 2025
Distribution
USA nationwide.

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Drug Recall Ongoing Historical recordClass II

Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01

by Eugia US LLC

Reason
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Recall initiated
April 21, 2025
Reported by FDA
May 7, 2025
Distribution
USA nationwide.

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Drug Recall Terminated Historical recordClass III

HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.

by OurPharma LLC

Reason
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Recall initiated
April 15, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99

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

Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02

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

DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15

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

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

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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

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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.

View recall →

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

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.

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