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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

DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

by PD-Rx Pharmaceuticals, Inc.

Reason: CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Recall initiated: December 4, 2024
Reported by FDA: January 1, 2025
Distribution: Distributed within US: FL, MS, WI

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Recall initiated: December 11, 2024
Reported by FDA: January 1, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Recall initiated: December 11, 2024
Reported by FDA: January 1, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Recall initiated: December 6, 2024
Reported by FDA: January 1, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.

by Macleods Pharmaceuticals Ltd

Reason: Failed Impurities/Degradation Specifications
Recall initiated: November 25, 2024
Reported by FDA: December 25, 2024
Distribution: Nationwide in the USA

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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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Data last updated: September 8, 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.