161 recalls, newest first
Reason Defective container: potential for non-sealed pouches which can lead to product leakage.
Reason Presence of particulate matter: glass
Reason CGMP Deviations: Out of specification for dissolution
Reason CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Reason Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81…
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Reason Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Reason Subpotent drug: out of specification results
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Reason Presence of foreign substance.
Reason Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Reason Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Reason Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Reason Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Reason Failed Content Uniformity Specifications
Reason Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Reason cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Reason Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on…
Reason Lack of Assurance of Sterility: Complaints of syringe breakage
Reason Lack of Assurance of Sterility.
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Reason Subpotent product in addition to having out-of-specification results for impurities.
Reason Defective container: lack of seal integrity.