Clear Eyes Redness Relief
Lack of Assurance of Sterility
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Stability Specifications
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
Lack of Assurance of Sterility
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).
Failed Dissolution Specifications
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Failed dissolution specifications.
Defective Delivery System: Possibility of no medication in the prefilled pen.
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Failed Dissolution Specifications
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.
Presence of Foreign Tablets/Capsules
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Superpotent Drug
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
CGMP Deviations: Potential contamination of raw material
CGMP Deviations: Potential contamination of raw material
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility