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28 reported ongoing
36 records in this archive. Latest source date Jul 16, 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: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class IIReported ongoing
Distribution: Nationwide within the United States
Failed Dissolution Specifications
Class IIReported ongoing
Distribution: Nationwide in the USA and PR
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Class IIReported ongoing
Distribution: Nationwide in the USA
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class IIReported ongoing
Distribution: Nationwide
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Class IIIReported terminated
Distribution: The recall product was distributed nationwide.
Failed Dissolution Specifications
Class IIReported ongoing
Distribution: Nationwide in the USA
Out of specification (OOS) for Spectroscopic Identification test by IR.
Class IIReported ongoing
Distribution: Nationwide in the USA
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class IIReported ongoing
Distribution: Nationwide in the USA.
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class IIReported ongoing
Distribution: Nationwide in the USA.
Failed Dissolution Specification
Class IIReported terminated
Distribution: Nationwide and Puerto Rico
Failed Dissolution Specification
Class IIReported terminated
Distribution: Nationwide and Puerto Rico
Failed Dissolution Specification
Class IIReported terminated
Distribution: Nationwide and Puerto Rico
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Class IIReported terminated
Distribution: Customers in 19 states: CA, FL, GA, IL, KY, LA, MI, MN, MS, NC, NJ, NY, OH, PA, RI, TN, TX, WA, WI; Puerto Rico
Failed Dissolution Specifications.
Class IIReported terminated
Distribution: Nationwide in the USA
Failed impurities/degradation specifications
Class IIReported terminated
Distribution: USA nationwide.
Failed Impurities/Degradation Specifications
Class IIReported terminated
Distribution: Nationwide
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 36 records, including 28 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.