Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,690 detailed records are currently available in this category.
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
Defective Delivery System; potential to have inaccurate dosage delivery
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the…
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.
Presence of Particulate Matter: identified as dried skin.
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
Presence of Particulate Matter
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
