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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

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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Drug Recall Terminated Historical recordClass II

Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Light Essentials, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-382-10, UPC 0 37000 72992 1

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, 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: 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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Drug Recall Terminated Historical recordClass I

Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant, Topical spray can 3.8 OZ (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-385-10, UPC 0 37000 74947 9

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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Drug Recall Terminated Historical recordClass I

Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g) cans, Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-387-10, UPC 0 37000 72974 7

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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Drug Recall Terminated Historical recordClass II

Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical Spray Can, Net WT 3.8 oz (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC 69423-386-10, UPC 0 37000 73034 7 OR UPC 0 12044 04475 9 (12 Pack, older label)

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

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: 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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Drug Recall Ongoing Historical recordClass II

Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90

by Ascend Laboratories, LLC

Reason: Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Recall initiated: December 29, 2023
Reported by FDA: January 24, 2024
Distribution: Nationwide

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Drug Recall Completed Historical recordClass I

Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736-378-02, Can UPC 3 63736 37882 0; Case UPC 1 03 63736 37882 7

by Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Reason: Chemical Contamination: presence of benzene
Recall initiated: December 21, 2023
Reported by FDA: January 24, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (case).

by Pfizer Inc.

Reason: Presence of Particulate Matter; identified as glass
Recall initiated: December 21, 2023
Reported by FDA: January 24, 2024
Distribution: Nationwide in the USA and Puerto Rico.

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Drug Recall Ongoing Historical recordClass I

8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14 (case).

by Pfizer Inc.

Reason: Presence of Particulate Matter; identified as glass
Recall initiated: December 21, 2023
Reported by FDA: January 24, 2024
Distribution: Nationwide in the USA and Puerto Rico.

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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.