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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 III

Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.

by SOMERSET THERAPEUTICS LLC

Reason: Subpotent product:out of specification assay results observed during long term stability testing.
Recall initiated: November 26, 2025
Reported by FDA: December 24, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10

by Golden State Medical Supply Inc.

Reason: Presence of Foreign Tablets/Capsules
Recall initiated: November 26, 2025
Reported by FDA: December 24, 2025
Distribution: Nationwide within the USA

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Drug Recall Ongoing Historical recordClass II

OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Recall initiated: October 31, 2025
Reported by FDA: December 24, 2025
Distribution: U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass II

Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Recall initiated: October 31, 2025
Reported by FDA: December 24, 2025
Distribution: U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass II

Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Recall initiated: October 31, 2025
Reported by FDA: December 24, 2025
Distribution: U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass II

darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Recall initiated: October 31, 2025
Reported by FDA: December 24, 2025
Distribution: U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass II

3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Recall initiated: October 31, 2025
Reported by FDA: December 24, 2025
Distribution: U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass II

Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Recall initiated: October 31, 2025
Reported by FDA: December 24, 2025
Distribution: U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass II

2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Recall initiated: October 31, 2025
Reported by FDA: December 24, 2025
Distribution: U.S.A. Nationwide

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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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Data last updated: October 30, 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.