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 Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Presence of Particulate Matter - found in reserve sample vials at the firm.
CGMP deviations: Lack of potency testing.
CGMP deviations: Lack of potency testing.
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
CGMP deviations: Lack of potency testing.
CGMP deviations: Lack of potency testing.
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and…
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
cGMP deviations: Product made at the same facility where product tested was sub-potent.
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two…
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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.
