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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 1,041–1,060 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.

by BRS Analytical Services, LLC

Reason
cGMP deviations and lack of assurance of sterility.
Recall initiated
April 23, 2025
Reported by FDA
May 14, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.

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
April 18, 2025
Reported by FDA
May 14, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass I

Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)

by Amneal Pharmaceuticals, LLC

Reason
Presence of Particulate Matter
Recall initiated
April 17, 2025
Reported by FDA
May 14, 2025
Distribution
Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product of Canada, NDC 54643-5649-1

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Recall initiated
April 25, 2025
Reported by FDA
May 7, 2025
Distribution
Distributed to Medical Facilities in MS and FL.

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Drug Recall Ongoing Historical recordClass II

Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Recall initiated
April 25, 2025
Reported by FDA
May 7, 2025
Distribution
Distributed to Medical Facilities in MS and FL.

View recall →

Drug Recall Ongoing Historical recordClass II

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]

by American Regent, Inc.

Reason
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Recall initiated
April 18, 2025
Reported by FDA
May 7, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.

by American Regent, Inc.

Reason
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Recall initiated
April 18, 2025
Reported by FDA
May 7, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15

by ACCORD HEALTHCARE, INC.

Reason
Subpotent
Recall initiated
April 10, 2025
Reported by FDA
May 7, 2025
Distribution
Nationwide US.

View recall →

Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17

by ACCORD HEALTHCARE, INC.

Reason
Subpotent
Recall initiated
April 10, 2025
Reported by FDA
May 7, 2025
Distribution
Nationwide US.

View recall →

Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.

by ACCORD HEALTHCARE, INC.

Reason
Subpotent
Recall initiated
April 10, 2025
Reported by FDA
May 7, 2025
Distribution
Nationwide US.

View recall →

Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17

by ACCORD HEALTHCARE, INC.

Reason
Subpotent
Recall initiated
April 10, 2025
Reported by FDA
May 7, 2025
Distribution
Nationwide US.

View recall →

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

View recall →

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.

View recall →

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

View recall →

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.

View recall →

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.

View recall →

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

View recall →

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

View recall →

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

View recall →

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

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.