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9 reported ongoing
19 records in this archive. Latest source date Jul 23, 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.
shortfill; reports of empty capsules.
Class IIReported ongoing
Distribution: US Nationwide.
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class IIReported ongoing
Distribution: USA Nationwide.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class IIReported ongoing
Distribution: Nationwide in the USA
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class IIReported ongoing
Distribution: USA Nationwide
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class IIReported ongoing
Distribution: USA Nationwide
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class IIReported ongoing
Distribution: USA Nationwide
Device & Drug Safety - Mislabeling
Not suppliedPublished notice; closure not supplied
Distribution: Aurobindo Pharma USA, Inc. began shipping of the subject batch to customers nationwide in January 2024. AuroHealth Over the Counter (OTC) bottle(s) with no label affixed to the ...
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class IReported ongoing
Distribution: NJ, NY & PA
Discoloration: Dotted and yellow spots on tablets
Class IIReported ongoing
Distribution: Nationwide in the USA
Discoloration: Dotted and yellow spots on tablets
Class IIReported ongoing
Distribution: Nationwide in the USA
Failed dissolution specifications - results obtained were below spec average.
Class IIReported terminated
Distribution: USA nationwide
cGMP deviations: Batch was released prior to approval.
Class IIReported terminated
Distribution: USA nationwide
cGMP deviations: Batch was released prior to approval.
Class IIReported terminated
Distribution: USA nationwide
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Class IIReported completed
Distribution: The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class IIReported completed
Distribution: Nationwide
Subpotent Drug: Out of Specification results for Assay
Class IIIReported terminated
Distribution: Nationwide in the USA.
Failed Impurities/Degradation Specifications
Class IIReported terminated
Distribution: USA Nationwide
Superpotent and Failed Tablet/Capsule Specifications
Class IIReported terminated
Distribution: Nationwide in the US
Failed Impurities/Degradation Specifications
Class IIIReported terminated
Distribution: Nationwide in the US
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 19 records, including 9 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.