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5 reported ongoing
33 records in this archive. Latest source date Apr 22, 2025.
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 - products manufactured in a shared facility with Ezetimibe tablets.
Class IIReported ongoing
Distribution: Within U.S - PA, VA, FL.
CGMP Deviations
Class IIReported ongoing
Distribution: PA
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Class IIReported terminated
Distribution: FL
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class IIReported ongoing
Distribution: Nationwide in the US
CGMP Deviations: Out of specification for dissolution
Class IIReported terminated
Distribution: USA Nationwide
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class IIReported terminated
Distribution: Product was distributed to one medical facility.
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Class IIReported terminated
Distribution: Nationwide in the USA
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class IIReported terminated
Distribution: Product was distrituded to three direct account in PA.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class IIReported ongoing
Distribution: Product was distrituded to three direct account in PA.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class IIReported ongoing
Distribution: Product was distrituded to three direct account in PA.
cGMP Deviations
Class IIReported terminated
Distribution: RemedyRepack distributed product to consignees nationwide within the United States
cGMP Deviations
Class IIReported terminated
Distribution: RemedyRepack distributed product to consignees nationwide within the United States
cGMP Deviations
Class IIReported terminated
Distribution: RemedyRepack distributed product to consignees nationwide within the United States
cGMP Deviations
Class IIReported terminated
Distribution: RemedyRepack distributed product to consignees nationwide within the United States
cGMP Deviations
Class IIReported terminated
Distribution: RemedyRepack distributed product to consignees nationwide within the United States
cGMP Deviations
Class IIReported terminated
Distribution: RemedyRepack distributed product to consignees nationwide within the United States
cGMP Deviations
Class IIReported terminated
Distribution: RemedyRepack distributed product to consignees nationwide within the United States
cGMP Deviations
Class IIReported terminated
Distribution: RemedyRepack distributed product to consignees nationwide within the United States
cGMP Deviations
Class IIReported terminated
Distribution: RemedyRepack distributed product to consignees nationwide within the United States
cGMP Deviations
Class IIReported terminated
Distribution: RemedyRepack distributed product to consignees nationwide within the United States
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 33 records, including 5 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.