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33 reported ongoing
87 records in this archive. Latest source date Sep 14, 2026. 1 published notices do not supply a closure status.
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 Stability Specifications
Not Yet ClassifiedReported ongoing
Distribution: U.S. Nationwide.
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class IIReported ongoing
Distribution: US Nationwide.
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class IIReported ongoing
Distribution: Nationwide in the USA
Failed Impurities/Degradation Specifications
Class IIIReported ongoing
Distribution: U.S. Nationwide
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Class IIReported ongoing
Distribution: Nationwide within the United States
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Class IIReported ongoing
Distribution: Nationwide within the United States
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Class IIReported ongoing
Distribution: Nationwide within the United States
Presence of glass particles
Not suppliedPublished notice; closure not supplied
Distribution: Not supplied
Presence of Particulate matter: Particulate matter identified as glass.
Class IReported ongoing
Distribution: U.S. Nationwide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class IIReported ongoing
Distribution: Nationwide in the USA.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class IIReported ongoing
Distribution: Nationwide in the USA.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class IIReported ongoing
Distribution: Nationwide in the USA.
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Class IIReported ongoing
Distribution: US Nationwide.
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Class IIIReported ongoing
Distribution: Nationwide within the USA
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class IIIReported ongoing
Distribution: Nationwide in the USA.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class IIReported ongoing
Distribution: U.S Nationwide.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class IIReported ongoing
Distribution: U.S Nationwide.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class IIReported ongoing
Distribution: U.S Nationwide.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class IIReported ongoing
Distribution: U.S Nationwide.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class IIReported ongoing
Distribution: U.S Nationwide.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 87 records, including 33 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.