1,523 recalls · Class III, newest first
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is…
Reason CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Reason Short Fill: some bottles contained less than 120-count per labeled claim.
Reason Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Reason Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Reason Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Reason Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Reason Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with…
Reason Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Reason Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the…
Reason Subpotent; fluocinolone acetonide.
Reason Presence of Particulate Matter; potential for charcoal particulates
Reason Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Reason Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Reason Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Reason Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
Reason Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10)…
Reason Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Reason Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of…