CLASS II ONGOING Drug recall · Reported 1 Jul 2020 · FDA Enforcement Report
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalled
Amneal Pharmaceuticals of New York is recalling amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 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-1352-2020
- 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, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10
Where it was distributed
Nationwide
Questions about this recall
Is amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalled?
Yes. Amneal Pharmaceuticals of New York recalled amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg on 29 May 2020. The recall is Class II and its status is Ongoing. Recall number D-1352-2020.
Why was it recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Which lots are affected?
HF08618A 6/30/2020 HF08718A 6/30/2020 HF15418A 7/31/2020 HF15518A 7/31/2020 HH11818A 9/30/2020 HJ00818A 9/30/2020 HJ00918A 9/30/2020 HJ01018A 9/30/2020
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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