CLASS II ONGOING Drug recall · Reported 1 Jul 2020 · FDA Enforcement Report
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk recalled
Amneal Pharmaceuticals of New York is recalling amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, distributed nationwide in the US. The recall was initiated on 29 May 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1354-2020
- FDA event ID
- 85781
- Recalling firm
- Amneal Pharmaceuticals of New York, Brookhaven, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 May 2020
- FDA classified
- 25 Jun 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Diabetes Medication
Timeline
| 29 May 2020 | Recall initiated by company | |
| 25 Jun 2020 | Classified by FDA | +27 days |
| 1 Jul 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Which lots are affected?
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 HK07719A 10/31/2020
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 85781This product is part of a recall event; the main page for the event is amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg recalled.
More recalls from Amneal Pharmaceuticals of New York
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
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| Drug | CLASS II | Oseltamivir Phosphate for Oral Suspension 6mg/ml (reconstituted) recalledOseltamivir Phosphate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenoxybenzamine Hydrochloride Capsules, USP 10mg recalled | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |