Duloxetine Delayed-Release Capsules, USP, 30mg recall — FDA D-0482-2024
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Labeling: Wrong Barcode
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Lack of Assurance of Sterility: Complaints of syringe breakage
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making…
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified…
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified…
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or…
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified…
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or…
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified…
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or…
Superpotent Drug: Due to overfilling of drug powder
CGMP Deviations
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Lack of Assurance of Sterility: Firm did not perform process validation.
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted…
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Lack of Assurance of Sterility: Firm did not perform process validation.
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