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: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality…
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality…
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality…
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA…
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl…
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality…
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality…
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA…
Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat…
Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl…
Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl…
Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD65475_10, EXP:…
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Labeling: Label Mixup: PERPHENAZINE, Tablet, 8 mg may have potentially been mislabeled as the following drug: NIFEdipine, Capsule, 10 mg, NDC 59762100401, Pedigree: AD52778_55, EXP:…
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2…
Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the following drug: COLESTIPOL HCL MICRONIZED, Tablet, 1 g, NDC 59762045001, Pedigree: AD56847_1,…
Labeling: Label Mixup: glyBURIDE MICRONIZED, Tablet, 3 mg may have potentially been mislabeled as the following drug: DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: W003154, EXP:…
Labeling: Label Mixup:CYANOCOBALAMIN, Tablet, 500 mcg was mislabled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002859, EXP: 6/7/2014. and may have potentially been…
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.
