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 Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Failed Dissolution Specifications: results were above specification.
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Product Mix-up: Incorrect diluent component included in the kit.
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
cGMP Deviations
cGMP Deviations
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
cGMP Deviations
cGMP Deviations
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
cGMP Deviations
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
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.
