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.
10,685 detailed records are currently available in this category.
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Lack of Assurance of Sterility
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Lack of Assurance of Sterility
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Super-Potent Drug: Out of specification potency results were obtained.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Super-Potent Drug: Out of specification potency results were obtained.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
CGMP Deviations
Presence of foreign tablets/capsules
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.
