Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
FDA Drug Recalls
490 recalls · Class II, newest first
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
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 II · Moderate risk
Exenatide Injection
Defective Delivery System: Possibility of no medication in the prefilled pen.
Class II · Moderate risk
Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
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 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
Class II · Moderate risk
Walgreens Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Walgreens Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Reliable -1 Laboratories
Lack of Assurance of Sterility
Class II · Moderate risk
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Lack of Assurance of Sterility
Class II · Moderate risk
2% Chlorhexidine Gluconate* Cloth
Cross Contamination with Other Products
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.