Drug establishmentActive, Registered FY2026FDA warning letter on file
Amneal Pharmaceuticals of New York, LLC
Amneal Pharmaceuticals of New York, LLC is an FDA-registered drug establishment (FEI 3005263655) located in , New York. The facility is active, registered for FY2026. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.
Recalls (1)
Recall data from openFDA enforcement reports (FDA Recall Enterprise System).
Establishment record
Inspection history
FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.
Questions
Is Amneal Pharmaceuticals of New York, LLC registered with the FDA?
Yes. Amneal Pharmaceuticals of New York, LLC is an FDA-registered drug establishment (FEI 3005263655) in , New York. Its current registration status is Active, Registered FY2026.
Has Amneal Pharmaceuticals of New York, LLC received an FDA warning letter?
Yes. FDA issued a warning letter to Amneal Pharmaceuticals of New York, LLC; the most recent is dated Aug 27, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).
What does Amneal Pharmaceuticals of New York, LLC do?
Amneal Pharmaceuticals of New York, LLC's FDA-registered operations are: ANALYSIS; LABEL; MANUFACTURE; PACK; REPACK.
Related facilities
Source: FDA public data · status as of 2026-06-01