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.
Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Presence of Particulate Matter - found in reserve sample vials at the firm.
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Subpotent drug - Product did not contain drug.
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Presence of Particulate Matter - found in reserve sample vials at the firm.
Presence of Particulate Matter: particulate matter identified after reconstitution.
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Some bottles may contain mixed strengths of the product.
Some bottles may contain mixed strengths of the product.
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Some bottles may contain mixed strengths of the product.
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled…
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled…
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled…
Failed dissolution specifications
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.
