FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated Aug 4, 2014
Reason Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine…
Class II · Moderate risk Terminated Jul 31, 2014
Reason Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Class II · Moderate risk Terminated Jul 30, 2014
Reason Lack of Assurance of Sterility; complaints of mold in the overpouch
Class II · Moderate risk Terminated Jul 30, 2014
Reason Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class II · Moderate risk Terminated Jul 25, 2014
Reason Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class II · Moderate risk Terminated Jul 24, 2014
Reason Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Class II · Moderate risk Terminated Jul 24, 2014
Reason Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class II · Moderate risk Terminated Jul 24, 2014
Reason Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class II · Moderate risk Terminated Jul 24, 2014
Reason Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class II · Moderate risk Terminated Jul 18, 2014
Reason CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk Terminated Jul 18, 2014
Reason Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of…
Class II · Moderate risk Terminated Jul 17, 2014
Reason CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk Terminated Jul 16, 2014
Reason Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at…
Class II · Moderate risk Terminated Jul 15, 2014
Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients…
Class II · Moderate risk Terminated Jul 12, 2014
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk Terminated Jul 12, 2014
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk Terminated Jul 12, 2014
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk Terminated Jul 12, 2014
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk Terminated Jul 12, 2014
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk Terminated Jul 12, 2014
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk Terminated Jul 12, 2014
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk Terminated Jul 12, 2014
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk Terminated Jul 11, 2014
Reason Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Class II · Moderate risk Terminated Jul 9, 2014
Reason cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert…
Class II · Moderate risk Terminated Jul 9, 2014
Reason cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert…