Class II · Moderate risk
Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection
Lack of assurance of sterility
FDA Drug Recalls
1,711 recalls, newest first
Class II · Moderate risk
Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Oral Suspension
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Oral Suspension
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Oral Suspension
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Class II · Moderate risk
Captopril Tablets
Failed Tablet/Capsule Specifications: out of specification for thickness.
Class I · High risk
Lactated Ringer's Irrigation
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Class III · Low risk
Fexofenadine HCl Tablets
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Class I · High risk
Ultra Zx Dietary Supplement
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
Class II · Moderate risk
Domperidone BP
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
Class III · Low risk
Air Compressed
Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
Class II · Moderate risk
Ergoloid Mesylates
Failed Impurities/Degradation Specifications: during long-term stability testing.
Class II · Moderate risk
Triest 80/10/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Triest 80/10/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Triest 70/20/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Estriol 5 Estradiol
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
ESTRIOL (weight/volume)
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
ESTRIOL (weight/volume)
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
ESTRIOL (weight/volume)
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Estriol
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
ESTRIOL (Testosterone USP)
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
ESTRIOL (Estradiol (E2)
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
ESTRIOL (Estradiol (E2)
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
ESTRIOL (Estradiol (E2)
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
ESTRIOL (weight/volume)
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.