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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 641–660 of 726 recalls

Class IIOngoing

Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148

GOLD STAR DISTRIBUTION INC

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

December 26, 2025 · DrugView details →

Class IIOngoing

LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz

GOLD STAR DISTRIBUTION INC

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

December 26, 2025 · DrugView details →

Class IIOngoing

NYQUIL 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

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 →

Class IIOngoing

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 IIIOngoing

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39

Cipla USA, Inc.

Failed PH Specifications

December 22, 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 →

Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313

HANDELNINE GLOBAL LLC

CGMP Deviations: product found to contain lead.

December 22, 2025 · DrugView details →

Class IIIOngoing

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

Zydus Pharmaceuticals (USA) Inc

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.

December 19, 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 →

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