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14 reported ongoing
19 records in this archive. Latest source date Aug 13, 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; product failed to meet 24-month stability testing acceptance criteria
Class IIReported ongoing
Distribution: US Nationwide.
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Class IIReported ongoing
Distribution: U.S.A. Nationwide
Lack of Assurance of Sterility
Class IIReported ongoing
Distribution: U.S. Nationwide
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class IIReported ongoing
Distribution: Nationwide in the US
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class IIReported ongoing
Distribution: Nationwide in the US
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Class IIReported ongoing
Distribution: US Nationwide.
Lack of Assurance of Sterility
Class IIReported ongoing
Distribution: US Nationwide.
Lack of Assurance of Sterility
Class IIReported ongoing
Distribution: US Nationwide.
Lack of Assurance of Sterility
Class IIReported ongoing
Distribution: US Nationwide.
CGMP Deviations: potential presence of Burkholderia cepacia complex
Class IIReported ongoing
Distribution: Nationwide in the USA
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class IIReported ongoing
Distribution: Nationwide
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class IIReported ongoing
Distribution: Nationwide
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class IIReported ongoing
Distribution: Nationwide
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class IIReported ongoing
Distribution: Nationwide
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Class IIReported completed
Distribution: Nationwide throughout the United States
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Class IIReported completed
Distribution: Nationwide in the USA
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Class IIIReported terminated
Distribution: USA Nationwide
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Class IIReported terminated
Distribution: USA Nationwide
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class IIIReported terminated
Distribution: Nationwide in the USA
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 19 records, including 14 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.