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: Lot not meeting specification for Unknown Max Related Compounds.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual…
Non-sterility
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual…
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making…
Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an…
cGMP deviations
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
cGMP deviations
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Lack of Assurance of Sterility
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.
