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10 reported ongoing
14 records in this archive. Latest source date Jun 3, 2026. 2 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.
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Class IIIReported ongoing
Distribution: Nationwide within the USA.
A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL.
Not suppliedPublished notice; closure not supplied
Distribution: Not supplied
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Class IIReported ongoing
Distribution: Nationwide within the USA
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Class IReported ongoing
Distribution: U.S.A. Nationwide
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class IIReported ongoing
Distribution: Distributed Nationwide in the USA
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class IIReported ongoing
Distribution: Distributed Nationwide in the USA
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class IIReported ongoing
Distribution: Distributed Nationwide in the USA
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class IIReported ongoing
Distribution: Distributed Nationwide in the USA
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class IIReported ongoing
Distribution: Distributed Nationwide in the USA
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Class IReported ongoing
Distribution: Nationwide in the USA
Product may contain an inert fiber identified as polypropylene fibers from the IV bag
Not suppliedPublished notice; closure not supplied
Distribution: The recalled product was distributed nationwide to wholesalers/distributors between the dates of 04/23/2024 to 11/8/2024 only.
Presence of Particulate Matter
Class IReported ongoing
Distribution: Nationwide in the US
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Class IIIReported completed
Distribution: Nationwide in the USA
Super potent due to bottles being overfilled
Not suppliedReported terminated
Distribution: Not supplied
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 14 records, including 10 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.