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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 561–580 of 1,000 recalls

Class IIOngoing

Claritin, 20 Count, UPC: 655708016305

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

December 26, 2025 · DrugView details →

Class IIOngoing

Bayer 2Pk- 25 CT

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

December 26, 2025 · DrugView details →

Ongoing

PEPCID COMPLETE - 25CT

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

December 26, 2025 · DrugView details →

Class IIOngoing

DAYQUIL COLD & FLU, 32CT/2PK

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

December 26, 2025 · DrugView details →

Class IIOngoing

Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

December 26, 2025 · DrugView details →

Class IIOngoing

Benadryl, 25'S 2PK Box, UPC 815556020316

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

December 26, 2025 · DrugView details →

Class IIOngoing

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

Baxter Healthcare Corporation

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

December 22, 2025 · DrugView details →

Class IIOngoing

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

Novo Nordisk Inc.

Presence of Particulate Matter: Hair was found in a prefilled syringe

December 19, 2025 · DrugView details →

Class IIOngoing

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

Novo Nordisk Inc.

Presence of Particulate Matter: Hair was found in a prefilled syringe

December 19, 2025 · DrugView details →

Class IIOngoing

INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01

Sato Pharmaceutical Co., Ltd

Failed Disintegration Specifications: above the time expected.

December 19, 2025 · DrugView details →

Class IIOngoing

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.

Imprimis NJOF, LLC

Presence of particulate matter - Glass like particles.

December 18, 2025 · DrugView details →

Class IIOngoing

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.

Imprimis NJOF, LLC

Presence of particulate matter - Glass like particles.

December 18, 2025 · DrugView details →

Class IIOngoing

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

Imprimis NJOF, LLC

Presence of particulate matter - Glass like particles.

December 18, 2025 · DrugView details →

Class IIOngoing

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

CareFusion 213, LLC

Lack of Assurance of Sterlity

December 17, 2025 · DrugView details →

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 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 →

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 →

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