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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 2026 recordClass III

traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Recall initiated: December 19, 2025
Reported by FDA: January 7, 2026
Distribution: Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13

by Glenmark Pharmaceuticals Inc., USA

Reason: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Recall initiated: December 30, 2025
Reported by FDA: January 7, 2026
Distribution: Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14

by Novo Nordisk Inc.

Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe
Recall initiated: December 19, 2025
Reported by FDA: January 7, 2026
Distribution: Nationwide within the United States.

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Drug Recall Ongoing 2026 recordClass II

Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14

by Novo Nordisk Inc.

Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe
Recall initiated: December 19, 2025
Reported by FDA: January 7, 2026
Distribution: Nationwide within the United States.

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Drug Recall Ongoing 2026 recordClass II

BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29

by CareFusion 213, LLC

Reason: Lack of Assurance of Sterlity
Recall initiated: December 17, 2025
Reported by FDA: January 7, 2026
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02.

by Merck Sharp & Dohme LLC

Reason: Presence of particulate matter: potential presence of metal particulates in the product.
Recall initiated: December 12, 2025
Reported by FDA: December 31, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03

by Merck Sharp & Dohme LLC

Reason: Presence of particulate matter: potential presence of metal particulates in the product.
Recall initiated: December 12, 2025
Reported by FDA: December 31, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08

by SUN PHARMA /TARO

Reason: Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Recall initiated: December 9, 2025
Reported by FDA: December 24, 2025
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01

by Preferred Pharmaceuticals, Inc.

Reason: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Recall initiated: November 17, 2025
Reported by FDA: December 24, 2025
Distribution: Natinowide in the USA

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Drug Recall Ongoing Historical recordClass III

Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.

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 III

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.

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 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

View recall →

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.