11,815 recalls · Class II, newest first
Reason Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Reason CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in…
Reason CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were…
Reason CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in…
Reason CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than…
Reason Subpotent; 18 month time point
Reason Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of…
Reason Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due…
Reason Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due…
Reason Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due…
Reason Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due…
Reason Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due…
Reason Failed Tablet/Capsule Specifications; Product contains broken tablets.
Reason Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a…
Reason Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reason Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Reason Lack of Assurance of Sterility; potential leakage from administrative port.