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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 Terminated Historical recordClass II

PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01

by Regenerative Processing Plant, LLC

Reason: Lack of Sterility Assurance
Recall initiated: December 10, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01

by Regenerative Processing Plant, LLC

Reason: Lack of Sterility Assurance
Recall initiated: December 10, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10

by Apothecus Pharmaceutical Corp.

Reason: CGMP deviations: out of specifications for assay
Recall initiated: November 22, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and 2 Distributors in Hong Kong

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Drug Recall Ongoing Historical recordClass II

Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05

by Provepharm Inc.

Reason: Discoloration
Recall initiated: November 22, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30

by Aurobindo Pharma USA Inc

Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Recall initiated: December 6, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

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Drug Recall Terminated Historical recordClass II

Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

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Drug Recall Terminated Historical recordClass II

Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

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Drug Recall Terminated Historical recordClass II

safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only.

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

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Drug Recall Terminated Historical recordClass II

Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

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Drug Recall Terminated Historical recordClass II

Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

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Drug Recall Terminated Historical recordClass II

Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

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Drug Recall Terminated Historical recordClass II

Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 50227-1002-3.

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

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Drug Recall Terminated Historical recordClass II

Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com.

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

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Drug Recall Terminated Historical recordClass II

Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

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Drug Recall Terminated Historical recordClass II

M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

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Drug Recall Terminated Historical recordClass II

Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.

by Keystone Industries

Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Recall initiated: November 14, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

View recall →

Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-040-20

by Mylan Institutional, Inc.

Reason: Subpotent and Superpotent Drug
Recall initiated: November 19, 2024
Reported by FDA: December 18, 2024
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-445-20

by Mylan Institutional, Inc.

Reason: Subpotent and Superpotent Drug
Recall initiated: November 19, 2024
Reported by FDA: December 18, 2024
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-041-20

by Mylan Institutional, Inc.

Reason: Subpotent and Superpotent Drug
Recall initiated: November 19, 2024
Reported by FDA: December 18, 2024
Distribution: Nationwide in the USA.

View recall →

Data last updated: October 31, 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.