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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 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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Drug Recall Ongoing Historical recordClass I

Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18

by Pfizer

Reason: Presence of particulate matter: glass
Recall initiated: December 21, 2023
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA, Netherlands and Libya

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Drug Recall Terminated Historical recordClass II

Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16

by Strides Pharma Inc.

Reason: Failed Dissolution Specifications
Recall initiated: December 29, 2023
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56

by Glenmark Pharmaceuticals Inc., USA

Reason: Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Recall initiated: January 4, 2024
Reported by FDA: January 31, 2024
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1

by IntegraDose Compounding Services LLC

Reason: Subpotent Drug
Recall initiated: January 12, 2024
Reported by FDA: January 31, 2024
Distribution: MN only

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Drug Recall Ongoing Historical recordClass III

Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11

by Amerisource Health Services LLC

Reason: Superpotent drug: Assay results were slightly above specification at the time zero point.
Recall initiated: December 26, 2023
Reported by FDA: January 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Secret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-380-10, UPC 0 37000 79884 2

by The Procter & Gamble Company

Reason: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Recall initiated: November 23, 2021
Reported by FDA: January 24, 2024
Distribution: Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana

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Drug Recall Terminated Historical recordClass II

Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-383-10, UPC: 0 37000 72986 0

by The Procter & Gamble Company

Reason: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Recall initiated: November 23, 2021
Reported by FDA: January 24, 2024
Distribution: Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana

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Drug Recall Terminated Historical recordClass II

Secret, Dry Spray, Aluminum chlorohydrate 23.5% Antiperspirant, Waterlily, Topical Spray Can, Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-381-10; UPC 0 37000 72372 1; 12/pack UPC 0 37000 72991 4

by The Procter & Gamble Company

Reason: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Recall initiated: November 23, 2021
Reported by FDA: January 24, 2024
Distribution: Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana

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Drug Recall Terminated Historical recordClass II

Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 00191 2

by The Procter & Gamble Company

Reason: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Recall initiated: November 23, 2021
Reported by FDA: January 24, 2024
Distribution: Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana

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Drug Recall Terminated Historical recordClass I

Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-380-10, UPC 0 37000 79884 2

by The Procter & Gamble Company

Reason: Chemical contamination: presence of benzene
Recall initiated: November 23, 2021
Reported by FDA: January 24, 2024
Distribution: Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana

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Data last updated: September 9, 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.