1,463 recalls · Class I, newest first
Reason Presence of Particulate Matter: Presence of glass particulates.
Reason Presence of Particulate Matter: Presence of glass particle.
Reason Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the…
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 Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Reason Marketed Without An Approved NDA/ANDA
Reason Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Reason Superpotent Drug: Due to overfilling of drug powder
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the…
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Reason Labeling: Label Mix-up
Reason Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Failed Content Uniformity Specifications
Reason Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Reason Presence of Particulate Matter: identified as glass.
Reason Presence of Particulate Matter: identified as glass.
Reason Presence of Particulate Matter: identified as glass.
Reason Microbial contamination of Non-Sterile Products
Reason Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product…
Reason Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets…
Reason Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).