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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 5,461–5,480 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
March 15, 2021
Reported by FDA
April 14, 2021
Distribution
NJ

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Drug Recall Terminated Historical recordClass II

Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1

by Kimberly-Clark Corporation

Reason
Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer
Recall initiated
February 1, 2021
Reported by FDA
April 14, 2021
Distribution
Nationwide in the US. Product also distributed in Canada.

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Drug Recall Terminated Historical recordClass II

ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4.

by Ferring Pharmaceuticals Inc

Reason
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Recall initiated
March 11, 2021
Reported by FDA
April 7, 2021
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 18031 5.

by Ferring Pharmaceuticals Inc

Reason
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Recall initiated
March 11, 2021
Reported by FDA
April 7, 2021
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.

by Zydus Pharmaceuticals (USA) Inc

Reason
Crystallization: customer complaints for crystallization in finished product.
Recall initiated
February 18, 2021
Reported by FDA
April 7, 2021
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass I

Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.

by Zydus Pharmaceuticals (USA) Inc

Reason
Crystallization: customer complaints for crystallization in finished product.
Recall initiated
February 18, 2021
Reported by FDA
April 7, 2021
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass III

Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.

by Cardinal Health Inc.

Reason
Temperature Abuse
Recall initiated
March 9, 2021
Reported by FDA
April 7, 2021
Distribution
AL, LA, MS, TN

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Drug Recall Terminated Historical recordClass II

0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09

by ICU Medical Inc

Reason
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Recall initiated
March 9, 2021
Reported by FDA
March 31, 2021
Distribution
Distributed Nationwide in the USA to include Puerto Rico

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Drug Recall Terminated Historical recordClass II

Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10

by Golden State Medical Supply Inc.

Reason
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Recall initiated
March 19, 2021
Reported by FDA
March 31, 2021
Distribution
Sold to two wholesalers/distributors under government contract located in PA and TX

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Drug Recall Terminated Historical recordClass I

Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.

by Adams.Secret.co

Reason
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Recall initiated
February 15, 2021
Reported by FDA
March 31, 2021
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5

by Adams.Secret.co

Reason
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Recall initiated
February 15, 2021
Reported by FDA
March 31, 2021
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01

by Teva Pharmaceuticals USA

Reason
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Recall initiated
March 4, 2021
Reported by FDA
March 24, 2021
Distribution
Distributed Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10

by Breckenridge Pharmaceutical, Inc

Reason
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Recall initiated
March 11, 2021
Reported by FDA
March 24, 2021
Distribution
Product was distributed nationwide

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Drug Recall Terminated Historical recordClass III

Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01

by Edge Pharma, LLC

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
December 22, 2020
Reported by FDA
March 24, 2021
Distribution
PA only

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Drug Recall Terminated Historical recordClass III

Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05

by Edge Pharma, LLC

Reason
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Recall initiated
February 17, 2021
Reported by FDA
March 24, 2021
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.

by Sagent Pharmaceuticals Inc

Reason
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Recall initiated
March 11, 2021
Reported by FDA
March 24, 2021
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Ongoing Historical recordClass II

Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01

by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Reason
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Recall initiated
January 27, 2021
Reported by FDA
March 24, 2021
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA

by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Reason
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Recall initiated
January 27, 2021
Reported by FDA
March 24, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Recall initiated
March 8, 2021
Reported by FDA
March 24, 2021
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330

by Direct Rx

Reason
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Recall initiated
March 2, 2021
Reported by FDA
March 24, 2021
Distribution
GA

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.