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.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the…
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
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.
