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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 PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-01

by BSO LLC

Reason: Presence of Particulate Matter: Glass particles were found in pellet vials.
Recall initiated: April 28, 2025
Reported by FDA: May 14, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01

by BSO LLC

Reason: Presence of Particulate Matter: Glass particles were found in pellet vials.
Recall initiated: April 28, 2025
Reported by FDA: May 14, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02

by RemedyRePack Inc.

Reason: CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Recall initiated: April 22, 2025
Reported by FDA: May 14, 2025
Distribution: Within U.S - PA, VA, FL.

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Drug Recall Ongoing Historical recordClass II

temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.

by Siddha Flower Essences, LLC.

Reason: CGMP Deviations
Recall initiated: April 28, 2025
Reported by FDA: May 14, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25

by Apollo Care, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: April 15, 2025
Reported by FDA: May 14, 2025
Distribution: MO

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Drug Recall Ongoing Historical recordClass II

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.

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

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Drug Recall Ongoing Historical recordClass II

Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.

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

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Drug Recall Ongoing Historical recordClass II

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15.

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

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Drug Recall Ongoing Historical recordClass II

Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.

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

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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

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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.

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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, 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

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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.

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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.

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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.

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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 →

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.