Agency classClass IIOur severity:Severe FDA (Drugs)·D-1354-2020·Announced 2020-07-01

Amneal Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

Amneal Pharmaceuticals is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the presence of NDMA impurity above acceptable intake levels in a prescription drug constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only. The recall is due to FDA analysis detecting the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level.

The affected product is distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ. The specific NDC number is 53746-0179-BULK. The recall covers lots with the following codes and expiration dates: HA01520A (1/31/2021), HA01620A (1/31/2021), HG01719A (7/31/2020), HG01819A (7/31/2020), HH09319A (8/31/2020), HH09419A (9/30/2020), HK07619A (10/31/2020), and HK07719A (10/31/2020).

The distribution pattern is listed as Nationwide. Patients and healthcare providers should check their inventory for these specific lot codes and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product: amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Category: Drug — Prescription Medication
Hazard: ndma-impurity
carcinogen-exposure

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Amneal Pharmaceuticals of New York, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Same manufacturer · Amneal Pharmaceuticals of New York, LLC

See all →

High
Amneal Recalls Exenatide Injection Pens Due to Potential Empty Delivery System
FDA (Drugs) · 2026-09-30
High
Methylergonovine Maleate tablets recalled for failed dissolution specifications
FDA (Drugs) · 2024-05-08
Severe
Vancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling
FDA (Drugs) · 2024-04-24
High
Divalproex Sodium 250 mg tablets recalled for failed dissolution specifications
FDA (Drugs) · 2024-04-03
Moderate
FDA Recalls Oseltamivir Phosphate Oral Suspension for Out-of-Specification Impurities
FDA (Drugs) · 2024-02-28

Same hazard · ndma impurity