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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 1,221–1,240 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover 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)

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Drug Recall Ongoing Historical recordClass II

Finasteride NDC# 82187-1003-1 Container Description: 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)

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Drug Recall Ongoing Historical recordClass II

Alprostadil Container Description: Amber color 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)

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Drug Recall Ongoing Historical recordClass II

Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover 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)

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Drug Recall Ongoing Historical recordClass I

BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.

by CareFusion 213, LLC

Reason
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Recall initiated
February 14, 2025
Reported by FDA
March 19, 2025
Distribution
Nationwide and Canada

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Drug Recall Completed Historical recordClass III

Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case

by Kowa Pharmaceuticals America

Reason
Presence of foreign tablets/capsules
Recall initiated
February 24, 2025
Reported by FDA
March 19, 2025
Distribution
PA, OH, and TX

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Drug Recall Terminated Historical recordClass II

Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Recall initiated
February 10, 2025
Reported by FDA
March 19, 2025
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Impurities/Degradation Specifications
Recall initiated
February 13, 2025
Reported by FDA
March 12, 2025
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Impurities/Degradation Specifications
Recall initiated
February 13, 2025
Reported by FDA
March 12, 2025
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.

by Safecor Health, LLC

Reason
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated
February 17, 2025
Reported by FDA
March 12, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.

by Safecor Health, LLC

Reason
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated
February 17, 2025
Reported by FDA
March 12, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.

by Safecor Health, LLC

Reason
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated
February 17, 2025
Reported by FDA
March 12, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.

by Safecor Health, LLC

Reason
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated
February 17, 2025
Reported by FDA
March 12, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.

by Safecor Health, LLC

Reason
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated
February 17, 2025
Reported by FDA
March 12, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Dissolution Specifications
Recall initiated
February 6, 2025
Reported by FDA
March 12, 2025
Distribution
Nationwide within in the USA.

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Drug Recall Completed Historical recordClass II

Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01.

by Turbare Manufacturing

Reason
Lack of Assurance of Sterility: due to a quality control process deviation
Recall initiated
February 18, 2025
Reported by FDA
March 5, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01.

by Wuxi Medical lnstrument Factory Co., Ltd.

Reason
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Recall initiated
February 12, 2025
Reported by FDA
March 5, 2025
Distribution
FL

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Drug Recall Completed Historical recordClass II

Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30

by Padagis US LLC

Reason
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Recall initiated
February 6, 2025
Reported by FDA
March 5, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.

by Alvogen, Inc

Reason
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Recall initiated
January 31, 2025
Reported by FDA
February 26, 2025
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiated
January 29, 2025
Reported by FDA
February 26, 2025
Distribution
Nationwide within the U.S

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.