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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 661–680 of 726 recalls

Class IIOngoing

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

SpecGx, LLC

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

December 16, 2025 · DrugView details →

Class IIOngoing

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

SpecGx, LLC

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

December 16, 2025 · DrugView details →

Class IIIOngoing

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

Alembic Pharmaceuticals Limited

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

December 16, 2025 · DrugView details →

Class IIIOngoing

Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72

NOVADOZ PHARMACEUTICALS LLC

Failed Impurities/Degradation Specifications

December 15, 2025 · DrugView details →

MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7

StuffbyNainax

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil

December 15, 2025 · DrugView details →

ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887

Medinatura New Mexico, inc.

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

December 12, 2025 · DrugView details →

Class IIOngoing

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

Merck Sharp & Dohme LLC

Presence of particulate matter: potential presence of metal particulates in the product.

December 12, 2025 · DrugView details →

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

Medinatura New Mexico, inc.

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

December 12, 2025 · DrugView details →

Class IIOngoing

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.

Merck Sharp & Dohme LLC

Presence of particulate matter: potential presence of metal particulates in the product.

December 12, 2025 · DrugView details →

Class IIOngoing

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

SUN PHARMA /TARO

Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

December 9, 2025 · DrugView details →

Class IIOngoing

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

Signature Formulations, LLC

cGMP Deviations

December 8, 2025 · DrugView details →

Class IIOngoing

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

Signature Formulations, LLC

cGMP Deviations

December 8, 2025 · DrugView details →

Class IIOngoing

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

Golden State Medical Supply Inc.

Presence of Foreign Tablets/Capsules

November 26, 2025 · DrugView details →

Class IIIOngoing

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.

SOMERSET THERAPEUTICS LLC

Subpotent product:out of specification assay results observed during long term stability testing.

November 26, 2025 · DrugView details →

Class IIIOngoing

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

Winder Laboratories, LLC

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

November 26, 2025 · DrugView details →

Class IIIOngoing

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.

SOMERSET THERAPEUTICS LLC

Subpotent product:out of specification assay results observed during long term stability testing.

November 26, 2025 · DrugView details →

Class IIIOngoing

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.

SOMERSET THERAPEUTICS LLC

Subpotent product:out of specification assay results observed during long term stability testing.

November 26, 2025 · DrugView details →

Class IIIOngoing

Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

November 26, 2025 · DrugView details →

Class IIOngoing

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.

Breckenridge Pharmaceutical, Inc.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

November 24, 2025 · DrugView details →

Class IIOngoing

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.

Breckenridge Pharmaceutical, Inc.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

November 24, 2025 · DrugView details →

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