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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 2,101–2,120 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01

by Baxter Healthcare Corporation

Reason
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Recall initiated
August 24, 2023
Reported by FDA
October 25, 2023
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16

by VistaPharm LLC

Reason
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Recall initiated
October 18, 2023
Reported by FDA
October 25, 2023
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass I

TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628

by Church & Dwight Inc

Reason
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Recall initiated
September 8, 2023
Reported by FDA
October 25, 2023
Distribution
Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.

by Dollar Tree Distribution, Inc.

Reason
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Recall initiated
October 5, 2023
Reported by FDA
October 25, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Dissolution Specifications
Recall initiated
October 4, 2023
Reported by FDA
October 25, 2023
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass III

MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05

by Imprimis NJOF, LLC

Reason
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Recall initiated
September 20, 2023
Reported by FDA
October 25, 2023
Distribution
Product was distributed to physician's offices nationwide.

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Drug Recall Completed Historical recordClass I

BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04

by Scynexis, Inc.

Reason
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Recall initiated
September 25, 2023
Reported by FDA
October 18, 2023
Distribution
Nationwide in the US.

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Drug Recall Ongoing Historical recordClass II

Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intrathecal use, Mfd. in India for Auromedics Pharma LLC., E Windsor, NJ, 08520, NDC 55150-385-01.

by Eugia US LLC

Reason
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Recall initiated
September 28, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979

by Imprimis NJOF, LLC

Reason
Subpotent: Failing Test Results for Epinephrine
Recall initiated
October 3, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11

by Amerisource Health Services LLC

Reason
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Recall initiated
September 1, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534

by Zydus Pharmaceuticals (USA) Inc

Reason
Failed Dissolution Specifications
Recall initiated
September 21, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass I

Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001111.

by Dr. Berne's Whole Health Products

Reason
Non-Sterility
Recall initiated
August 26, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

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Drug Recall Ongoing Historical recordClass II

Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001111.

by Dr. Berne's Whole Health Products

Reason
CGMP Deviations
Recall initiated
August 26, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

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Drug Recall Ongoing Historical recordClass II

Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, Certified Organic by Organic Certifiers.

by Dr. Berne's Whole Health Products

Reason
CGMP Deviations
Recall initiated
August 26, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

View recall →

Drug Recall Ongoing Historical recordClass II

Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com.

by Dr. Berne's Whole Health Products

Reason
CGMP Deviations
Recall initiated
August 26, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

View recall →

Drug Recall Ongoing Historical recordClass II

Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001036

by Dr. Berne's Whole Health Products

Reason
CGMP Deviations
Recall initiated
August 26, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility:
Recall initiated
September 21, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility:
Recall initiated
September 21, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility:
Recall initiated
September 21, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1

by Central Admixture Pharmacy Services Inc

Reason
Lack of assurance of sterility:
Recall initiated
September 21, 2023
Reported by FDA
October 11, 2023
Distribution
Nationwide in the USA

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.