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.
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir…
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir…
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S.…
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and…
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Presence of Particulate Matter; contains visible particulate matter identified as mold.
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.
