Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
FDA Drug Recalls
560 recalls, newest first
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Unclassified
Nystatin Cream
Failed Stability Specifications
Unclassified
0.9% Sodium Chloride Injection
Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
Class II · Moderate risk
Chlorthalidone Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Lidocaine Ointment USP
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Class III · Low risk
Trokendi XR
Failed dissolution specifications.
Class II · Moderate risk
Exenatide Injection
Defective Delivery System: Possibility of no medication in the prefilled pen.
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Class II · Moderate risk
Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
Class III · Low risk
Fluphenazine Hydrochloride Tablets
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Class III · Low risk
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Ramipril Capsules USP
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Class I · High risk
Thyroid Tablets
Superpotent Drug
Class II · Moderate risk
Prasugrel HCI
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Class II · Moderate risk
Broadway Joe's Pain Cream
CGMP Deviations: Potential contamination of raw material
Class II · Moderate risk
Broadway Joe's Pain Cream
CGMP Deviations: Potential contamination of raw material
Class II · Moderate risk
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Lack of Assurance of Sterility
Class II · Moderate risk
Lubricant Eye Drops-Cameron Pharmaceuticals
Lack of Assurance of Sterility
Class II · Moderate risk
Major LubriFresh P.M. Nighttime Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
TRP The Relief Products* Gentle Eyes Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Reliable-1 Laboratories Lubricating Tears
Lack of Assurance of Sterility