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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 III

Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3

by Biocompatibles UK, Ltd.

Reason: Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Recall initiated: August 15, 2024
Reported by FDA: December 18, 2024
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37

by Lannett Company Inc.

Reason: Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Recall initiated: October 25, 2024
Reported by FDA: December 11, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com.

by Generitech Corporation

Reason: CGMP Deviations: Inconsistency in the water systems.
Recall initiated: November 22, 2024
Reported by FDA: December 11, 2024
Distribution: CA

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30

by AvKARE

Reason: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Recall initiated: November 27, 2024
Reported by FDA: December 11, 2024
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30

by AvKARE

Reason: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Recall initiated: November 27, 2024
Reported by FDA: December 11, 2024
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30

by AvKARE

Reason: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Recall initiated: November 27, 2024
Reported by FDA: December 11, 2024
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ

by Rising Pharma Holding, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Recall initiated: November 19, 2024
Reported by FDA: December 11, 2024
Distribution: Nationwide.

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ

by Rising Pharma Holding, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Recall initiated: November 19, 2024
Reported by FDA: December 11, 2024
Distribution: Nationwide.

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

by Rising Pharma Holding, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Recall initiated: November 19, 2024
Reported by FDA: December 11, 2024
Distribution: Nationwide.

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Drug Recall Ongoing Historical recordClass II

Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28

by AvKARE

Reason: Labeling: Label Mix-Up
Recall initiated: October 18, 2024
Reported by FDA: December 11, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28

by AvKARE

Reason: Labeling: Label Mix-Up
Recall initiated: October 18, 2024
Reported by FDA: December 11, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets

by Zydus Pharmaceuticals (USA) Inc

Reason: Labeling: Not Elsewhere Classified - Wrong NDC number
Recall initiated: November 14, 2024
Reported by FDA: December 11, 2024
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 bottle, 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: November 14, 2024
Reported by FDA: December 11, 2024
Distribution: PA, OH, PR

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Recall initiated: November 14, 2024
Reported by FDA: December 11, 2024
Distribution: PA, OH, PR

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06

by Amerisource Health Services LLC

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Recall initiated: November 14, 2024
Reported by FDA: December 11, 2024
Distribution: PA, OH, PR

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Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiated: November 1, 2024
Reported by FDA: December 11, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiated: November 1, 2024
Reported by FDA: December 11, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiated: November 1, 2024
Reported by FDA: December 11, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiated: November 1, 2024
Reported by FDA: December 11, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiated: November 1, 2024
Reported by FDA: December 11, 2024
Distribution: Nationwide in the USA

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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.