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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 I

PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.

by Denver Solutions, LLC DBA Leiters Health

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Recall initiated: December 28, 2023
Reported by FDA: February 7, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.

by Denver Solutions, LLC DBA Leiters Health

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Recall initiated: December 28, 2023
Reported by FDA: February 7, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.

by Denver Solutions, LLC DBA Leiters Health

Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Recall initiated: December 28, 2023
Reported by FDA: February 7, 2024
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30

by Golden State Medical Supply Inc.

Reason: Failed Dissolution Specifications
Recall initiated: January 12, 2024
Reported by FDA: February 7, 2024
Distribution: Illinois only

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Drug Recall Ongoing Historical recordClass II

Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30

by Teva Pharmaceuticals USA, Inc

Reason: Failed Dissolution Specifications
Recall initiated: January 8, 2024
Reported by FDA: February 7, 2024
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

by Lupin Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications
Recall initiated: January 3, 2024
Reported by FDA: February 7, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

by Haleon US Holdings LLC

Reason: Microbial Contamination of Non-Sterile Products
Recall initiated: December 26, 2023
Reported by FDA: January 31, 2024
Distribution: USA nationwide

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Drug Recall Ongoing Historical recordClass I

Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

by Haleon US Holdings LLC

Reason: Microbial Contamination of Non-Sterile Products
Recall initiated: December 26, 2023
Reported by FDA: January 31, 2024
Distribution: USA nationwide

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Drug Recall Completed Historical recordClass II

Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: January 18, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: January 18, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: January 18, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: January 18, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-613-81.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: January 18, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: January 18, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: January 18, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-639-83.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: January 18, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: January 18, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: January 18, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated: January 18, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.

by BE PHARMACEUTICALS AG

Reason: Lack of Sterility Assurance: Aseptic process simulation failure.
Recall initiated: January 10, 2024
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Data last updated: November 1, 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.