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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

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

by Lupin Pharmaceuticals Inc.

Reason: Defective container - seal not adhering to bottles
Recall initiated: November 5, 2025
Reported by FDA: December 17, 2025
Distribution: Nationwide.

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02

by Cipla USA, Inc.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recall initiated: November 14, 2025
Reported by FDA: December 17, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02

by Cipla USA, Inc.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recall initiated: November 14, 2025
Reported by FDA: December 17, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02

by Cipla USA, Inc.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recall initiated: November 14, 2025
Reported by FDA: December 17, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass III

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01

by Winder Laboratories, LLC

Reason: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Recall initiated: November 26, 2025
Reported by FDA: December 17, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass III

Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.

by Glenmark Pharmaceuticals Inc., USA

Reason: Cross Contamination with Other Products
Recall initiated: November 18, 2025
Reported by FDA: December 17, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01

by Fagron Compounding Services

Reason: Incorrect Product Formulation
Recall initiated: November 20, 2025
Reported by FDA: December 17, 2025
Distribution: U.S. Nationwide.

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Drug Recall Ongoing Historical recordClass II

Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01

by Lupin Pharmaceuticals Inc.

Reason: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Recall initiated: November 13, 2025
Reported by FDA: December 17, 2025
Distribution: FL, MA, MI & OH

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Drug Recall Ongoing Historical recordClass III

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

by Dr. Reddy's Laboratories, Inc.

Reason: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Recall initiated: November 11, 2025
Reported by FDA: December 17, 2025
Distribution: Distributed Nationwide

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Drug Recall Ongoing Historical recordClass II

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.

by Cipla USA, Inc.

Reason: Failed stability specifications: Out of specification for hardness test
Recall initiated: October 24, 2025
Reported by FDA: December 17, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.

by Cipla USA, Inc.

Reason: Failed stability specifications: Out of specification for hardness test
Recall initiated: October 24, 2025
Reported by FDA: December 17, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recall initiated: November 24, 2025
Reported by FDA: December 10, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recall initiated: November 24, 2025
Reported by FDA: December 10, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.

by Safecor Health, LLC

Reason: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Recall initiated: October 10, 2025
Reported by FDA: December 10, 2025
Distribution: Distributed in Massachusetts

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Drug Recall Ongoing Historical recordClass II

Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.

by Blossom Pharmaceuticals

Reason: cGMP deviations
Recall initiated: October 31, 2025
Reported by FDA: December 10, 2025
Distribution: USA Nationwide

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Data last updated: September 6, 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.