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.
Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG…
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
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…
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: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and…
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…
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy,…
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…
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Subpotent; bupivacaine
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Failed Dissolution Specifications; 36 month stability timepoint
Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from…
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
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.
