FDA Drug Recalls (Class II)

Amneal Recalls Tramadol HCl Tablets Due to NDSRI Impurity

Amneal Pharmaceuticals LLC has issued a voluntary Class II drug recall for Tramadol Hydrochloride Tablets USP 50mg (500-count bottles) due to detection of N-nitroso-desmethyl-tramadol (NDSRI) impurity exceeding specification limits at the 24-month stability interval. Two lots totaling 29,542 bottles are affected: AM230987 (exp. 05/2026) and AR232387 (exp. 12/2026). Distribution was nationwide within the United States.

Appco Pharma Prazosin 2mg Capsules Recall - Nitrosamine Impurity

FDA has classified a Class II voluntary recall initiated by Appco Pharma LLC for Prazosin Hydrochloride Capsules, USP 2mg due to a cGMP deviation involving detection of N-nitroso-prazosin impurity C (NNP) above acceptable limits. The recall affects 5 lots totaling 58,896 bottles distributed nationwide in the U.S. The affected product was manufactured for Biocon Pharma Inc. and includes lots expiring through May 2027.

K.C. Pharmaceuticals Recalls 74,016 Bottles of Sterile Eye Drops

K.C. Pharmaceuticals, Inc. initiated a voluntary Class II recall of 74,016 bottles of Rugby brand Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 oz bottles. The recall was initiated on March 3, 2026, due to Lack of Assurance of Sterility. Affected lots are SY24K01 and SY24K02, both expiring 09/30/26. The FDA classified this as a Class II recall on March 31, 2026, and distribution was nationwide in the US.

Artificial Tears Sterile Lubricant Eye Drops Recall - 589,848 Bottles, Lack of Sterility Assurance

FDA classified a Class II recall for K.C. Pharmaceuticals' Artificial Tears Sterile Lubricant Eye Drops (Leader brand) distributed nationwide. The recall affects 589,848 bottles due to lack of assurance of sterility. Affected lot numbers include AT24D01, AT24E01, AT24E02, and AT24G01 with expiration dates through July 2026. Healthcare providers and patients should verify product stock against the recalled lot codes.

Appco Pharma Prazosin Recall - 88,008 Bottles, Class II

FDA classified a Class II voluntary recall by Appco Pharma LLC for Prazosin Hydrochloride Capsules, USP 1mg (100-count bottles) distributed nationwide. The recall affects 88,008 bottles across 7 lots due to a cGMP deviation: detection of N-nitroso-prazosin impurity C (NNP) above acceptable limits. The affected lots span expiration dates from March 2026 through June 2027.