Drug establishmentActive, Registered FY2026FDA warning letter on file

Amneal Pharmaceuticals, LLC

Amneal Pharmaceuticals, LLC is an FDA-registered drug establishment (FEI 3004488497) located in , New Jersey. The facility is active, registered for FY2026. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Aug 27, 2025

CGMP/Finished Pharmaceuticals/Adulterated

Read the letter on FDA.gov ›

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 (8)

Mar 19, 2026 Class II

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).

Ongoing

Mar 18, 2026 Class I

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.

Ongoing

Aug 18, 2025 Class II

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.

Ongoing

Jun 2, 2025 Class I

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

Ongoing

Apr 17, 2025 Class I

Presence of Particulate Matter

Ongoing

Aug 1, 2024 Class III

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

Completed

Mar 25, 2024 Class II

Failed Dissolution Specifications

Completed

Mar 21, 2024 Class I

Superpotent Drug: Due to overfilling of drug powder

Terminated

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number

3004488497

Address

65 Readington Rd Bldg B, , New Jersey

Establishment type

Drug establishment

Products / operations

ANALYSIS; LABEL; MANUFACTURE; PACK

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

None on file

Form 483 observations

None on file

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, LLC registered with the FDA?

Yes. Amneal Pharmaceuticals, LLC is an FDA-registered drug establishment (FEI 3004488497) in , New Jersey. Its current registration status is Active, Registered FY2026.

Has Amneal Pharmaceuticals, LLC received an FDA warning letter?

Yes. FDA issued a warning letter to Amneal Pharmaceuticals, LLC; the most recent is dated Aug 27, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Amneal Pharmaceuticals, LLC do?

Amneal Pharmaceuticals, LLC's FDA-registered operations are: ANALYSIS; LABEL; MANUFACTURE; PACK.

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Source: FDA public data · status as of 2026-06-01