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7 reported ongoing
54 records in this archive. Latest source date Aug 3, 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.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIReported terminated
Distribution: Product was distributed nationwide
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIReported terminated
Distribution: Product was distributed nationwide
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIReported terminated
Distribution: Product was distributed nationwide
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIReported terminated
Distribution: Product was distributed nationwide
Out-of-specification impurity test result observed at 18-month long term stability time point.
Class IIIReported terminated
Distribution: Product Distributed in NY and OH.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class IIIReported terminated
Distribution: Nationwide in the USA and Puerto Rico
Subpotent Drug
Class IIIReported terminated
Distribution: nationwide within the United States
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class IIIReported terminated
Distribution: Nationwide in the USA and Puerto Rico
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class IIReported terminated
Distribution: Product was distributed to major distributors who may have further distributed the product nationwide.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class IIReported terminated
Distribution: Product was distributed to major distributors who may have further distributed the product nationwide.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class IIReported terminated
Distribution: Product was distributed to major distributors who may have further distributed the product nationwide.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class IIReported terminated
Distribution: Product was distributed to major distributors who may have further distributed the product nationwide.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class IIReported terminated
Distribution: Product was distributed to major distributors who may have further distributed the product nationwide.
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Class IIReported terminated
Distribution: Distributed Nationwide in the USA.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 54 records, including 7 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.