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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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Showing 661–680 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass I

ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863

by Medinatura New Mexico, inc.

Reason
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Recall initiated
December 12, 2025
Reported by FDA
January 14, 2026
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing 2026 recordClass II

Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493

by SpecGx, LLC

Reason
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Recall initiated
December 16, 2025
Reported by FDA
January 14, 2026
Distribution
Nationwide

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Drug Recall Ongoing 2026 recordClass II

Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.

by SpecGx, LLC

Reason
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Recall initiated
December 16, 2025
Reported by FDA
January 14, 2026
Distribution
Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA

by Signature Formulations, LLC

Reason
cGMP Deviations
Recall initiated
December 8, 2025
Reported by FDA
January 14, 2026
Distribution
AZ only

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Drug Recall Ongoing 2026 recordClass II

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA

by Signature Formulations, LLC

Reason
cGMP Deviations
Recall initiated
December 8, 2025
Reported by FDA
January 14, 2026
Distribution
AZ only

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Drug Recall Ongoing 2026 recordClass II

Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.

by Imprimis NJOF, LLC

Reason
Presence of particulate matter - Glass like particles.
Recall initiated
December 18, 2025
Reported by FDA
January 14, 2026
Distribution
U.S Nationwide

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Drug Recall Ongoing 2026 recordClass II

Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.

by Imprimis NJOF, LLC

Reason
Presence of particulate matter - Glass like particles.
Recall initiated
December 18, 2025
Reported by FDA
January 14, 2026
Distribution
U.S Nationwide

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Drug Recall Ongoing 2026 recordClass II

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

by Imprimis NJOF, LLC

Reason
Presence of particulate matter - Glass like particles.
Recall initiated
December 18, 2025
Reported by FDA
January 14, 2026
Distribution
U.S Nationwide

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Drug Recall Ongoing 2026 recordClass III

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30

by Alembic Pharmaceuticals Limited

Reason
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Recall initiated
December 16, 2025
Reported by FDA
January 14, 2026
Distribution
US Nationwide and PR.

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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.

View recall →

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.

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

Data last updated:

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.

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