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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 II

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98

by Cipla USA, Inc.

Reason: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Recall initiated: October 23, 2024
Reported by FDA: November 20, 2024
Distribution: USA nationwide.

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Drug Recall Ongoing Historical recordClass II

Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009

by Trinity Gold Nutrition

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Recall initiated: November 6, 2024
Reported by FDA: November 20, 2024
Distribution: Nationwide within the United States; additionally Canada, England, and Australia.

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Drug Recall Ongoing Historical recordClass II

Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).

by Direct Rx

Reason: Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Recall initiated: August 9, 2024
Reported by FDA: November 13, 2024
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass I

Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317

by Staska Pharmaceuticals, Inc.

Reason: Presence of Particulate Matter: Presence of glass particulates.
Recall initiated: September 30, 2024
Reported by FDA: November 13, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01

by Baxter Healthcare Corporation

Reason: Labeling: Missing Label
Recall initiated: October 30, 2024
Reported by FDA: November 13, 2024
Distribution: Nationwide within the USA

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Drug Recall Ongoing Historical recordClass II

Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.

by VIONA PHARMACEUTICALS INC

Reason: Crystallization
Recall initiated: October 29, 2024
Reported by FDA: November 13, 2024
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Impurities/Degradation Specification
Recall initiated: October 22, 2024
Reported by FDA: November 13, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Impurities/Degradation Specification
Recall initiated: October 22, 2024
Reported by FDA: November 13, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

by FDC Limited

Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Recall initiated: October 29, 2024
Reported by FDA: November 13, 2024
Distribution: Distributed to one Us Distributor in NJ.

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Drug Recall Ongoing Historical recordClass III

Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018

by Denison Pharmaceuticals, LLC

Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Recall initiated: September 25, 2024
Reported by FDA: November 13, 2024
Distribution: Product was distributed to two accounts that may have distributed the product further to the Retail Level.

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Drug Recall Ongoing Historical recordClass III

Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155

by Denison Pharmaceuticals, LLC

Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Recall initiated: September 25, 2024
Reported by FDA: November 13, 2024
Distribution: Product was distributed to two accounts that may have distributed the product further to the Retail Level.

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recall initiated: October 10, 2024
Reported by FDA: November 6, 2024
Distribution: Nationwide in the USA and PR

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recall initiated: October 10, 2024
Reported by FDA: November 6, 2024
Distribution: Nationwide in the USA and PR

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recall initiated: October 10, 2024
Reported by FDA: November 6, 2024
Distribution: Nationwide in the USA and PR

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Drug Recall Terminated Historical recordClass II

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

by BLI International, Inc.

Reason: Superpotent Drug: Stability failure for assay at 6 months test time-point.
Recall initiated: October 21, 2024
Reported by FDA: November 6, 2024
Distribution: Product was shipped to two private label customers ( OH & MO) as a final packaged product.

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

by Dr. Reddy's Laboratories, Inc.

Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recall initiated: October 9, 2024
Reported by FDA: November 6, 2024
Distribution: USA Nationwide.

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

by Dr. Reddy's Laboratories, Inc.

Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recall initiated: October 9, 2024
Reported by FDA: November 6, 2024
Distribution: USA Nationwide.

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.

by Dr. Reddy's Laboratories, Inc.

Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recall initiated: October 9, 2024
Reported by FDA: November 6, 2024
Distribution: USA Nationwide.

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Drug Recall Ongoing Historical recordClass II

OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.

by Akron Pharma, Inc.

Reason: CGMP Deviations
Recall initiated: October 15, 2024
Reported by FDA: October 30, 2024
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,

by C & A Naturistics

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Recall initiated: October 8, 2024
Reported by FDA: October 30, 2024
Distribution: Nationwide within the United States

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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.