FDA Drug Recalls

436 recalls, newest first

Class II · Moderate risk Completed Jan 17, 2024

Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.

Henry Schein Inc. and Glove Club HSI Gloves Inc. NDC 42023-159-25 D-0342-2024

Class II · Moderate risk Completed Jan 2, 2024

Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA…

Reason Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.

Dr. Reddy's Laboratories, Inc. NDC 55111-180-15 D-0223-2024

Class I · High risk Completed Dec 21, 2023

Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp…

Reason Chemical Contamination: presence of benzene

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company NDC 63736-378-02 D-0236-2024

Class II · Moderate risk Completed Nov 29, 2023

ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135…

Reason STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source…

STAQ Pharma, Inc. NDC 73177-0109-26 D-0147-2024

Class I · High risk Completed Nov 22, 2023

TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight…

Reason Chemical Contamination; presence of benzene.

Insight Pharmaceuticals Corporation D-0151-2024

Class II · Moderate risk Completed Nov 22, 2023

ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC…

Reason Lack of assurance of sterility.

Wells Pharma of Houston LLC NDC 73702-131-10 D-0141-2024

Class III · Low risk Completed Nov 20, 2023

Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles…

Reason Failed Dissolution Specifications

Siegfried Barbera, SL NDC 0078-1077-66 D-0149-2024

Class I · High risk Completed Nov 17, 2023

Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc…

Reason Defective Container: powder may leak out of the pouch

InvaGen Pharmaceuticals, Inc. NDC 69097-964-53 D-0220-2024

Class II · Moderate risk Completed Nov 14, 2023

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation…

Reason Failed pH Specifications

Baxter Healthcare Corporation NDC 36000-012-25 D-0146-2024

Class II · Moderate risk Completed Oct 19, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd…

Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Zydus Pharmaceuticals (USA) Inc NDC 68382-257-01 D-0098-2024

Class II · Moderate risk Completed Oct 19, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd…

Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Zydus Pharmaceuticals (USA) Inc NDC 68382-256-01 D-0097-2024

Class II · Moderate risk Completed Oct 19, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi…

Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Zydus Pharmaceuticals (USA) Inc NDC 68382-255-01 D-0096-2024

Class I · High risk Completed Sep 25, 2023

BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey…

Reason Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial…

Scynexis, Inc. NDC 75788-115-04 D-0042-2024

Class II · Moderate risk Completed Aug 25, 2023

BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml)…

Reason Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond…

CareFusion 213, LLC NDC 54365-400-31 D-1168-2023

Class III · Low risk Completed Aug 17, 2023

Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC…

Reason Cross contamination with other products

Lundbeck LLC NDC 67386-211-65 D-1142-2023

Class III · Low risk Completed Aug 16, 2023

Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann…

Reason Failed dissolution specifications: below specification results at stability 12-month

Esperion NDC 72426-818-03 D-1143-2023

Class III · Low risk Completed Aug 14, 2023

Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare…

Reason Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

Baxter Healthcare Corporation NDC 10019-079-01 D-1103-2023