FDA Drug Recalls

17,898 recalls, newest first

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. -…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-1 D-0157-2024

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. -…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-4 D-0156-2024

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. -…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-3 D-0155-2024

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-5 D-0154-2024

Class III · Low risk Terminated Dec 8, 2023

Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA…

Reason Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine…

Azurity Pharmaceuticals, Inc. NDC 52652-9001-1 D-0213-2024

Class II · Moderate risk Terminated Dec 4, 2023

Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury…

Reason Failed Impurities/Degradation Specifications

Sun Pharmaceutical Industries INC NDC 62756-589-88 D-0150-2024

Class I · High risk Ongoing Nov 29, 2023

Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7…

Reason Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

Meta Herbal D-0206-2024

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 II · Moderate risk Terminated Nov 22, 2023

Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset…

Reason Presence of Particulate Matter.

AnazaoHealth Corporation NDC 72682-8721-3 D-0204-2024

Class II · Moderate risk Terminated Nov 22, 2023

B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile…

Reason Presence of Particulate Matter.

AnazaoHealth Corporation NDC 72682-2230-3 D-0203-2024

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 Terminated Nov 22, 2023

Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202…

Reason Failed Dissolution Specifications

Lupin Pharmaceuticals Inc. NDC 70748-153-01 D-0148-2024

Class I · High risk Ongoing Nov 22, 2023

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue…

Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

Novartis Pharmaceuticals Corporation NDC 0078-0110-22 D-0144-2024

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 Terminated Nov 22, 2023

buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical…

Reason Failed Dissolution Specifications

Sun Pharmaceutical Industries INC NDC 47335-738-86 D-0137-2024

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