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30 reported ongoing
46 records in this archive. Latest source date May 1, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Failed Dissolution Specifications:
Class IIReported terminated
Distribution: Nationwide in the USA
Presence of Foreign Tablets/Capsules
Class IIReported ongoing
Distribution: Nationwide within the United States
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class IIReported ongoing
Distribution: Nationwide in the USA
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class IIReported ongoing
Distribution: Nationwide in the USA
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class IIReported ongoing
Distribution: Nationwide in the USA
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class IIReported ongoing
Distribution: Nationwide in the USA
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class IIReported ongoing
Distribution: PA, OH, PR
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class IIReported ongoing
Distribution: PA, OH, PR
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class IIReported ongoing
Distribution: PA, OH, PR
Failed Dissolution Specifications
Class IReported ongoing
Distribution: US Nationwide.
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class IIReported ongoing
Distribution: Nationwide in the USA
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Class IIIReported terminated
Distribution: Nationwide in the USA
CGMP Deviations
Class IIReported terminated
Distribution: USA Nationwide
Failed Impurities/Degradation Specification.
Class IIReported terminated
Distribution: Nationwide in the USA
Superpotent drug: Assay results were slightly above specification at the time zero point.
Class IIIReported ongoing
Distribution: Nationwide in the USA
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Class IIIReported terminated
Distribution: Nationwide in the USA
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Class IIReported terminated
Distribution: Nationwide in the USA
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIReported terminated
Distribution: Nationwide USA
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIReported terminated
Distribution: Nationwide USA
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIReported terminated
Distribution: Nationwide USA
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 46 records, including 30 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.