Reported Jul 1, 2020 · Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal…
Amneal Pharmaceuticals of New York, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amneal Pharmaceuticals of New York, LLC · 50 Horseblock Rd · Brookhaven, NY · 11719-9509
Is this the product you have?
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only
- Distributed byAmneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
- Lot codes and dates
HB10019A03-2021HB10119A03-2021HB10219A03-2021HB10319A03-2021HD02119A04-2021HD03319A04-2021HF09118A06-2020HF11618A06-2020HF15218A07-2020HF15318A07-2020HJ01418A09-2020HJ01518A09-2020HJ01618A09-2020HJ01718A09-2020HJ04718A09-2020HK03218A10-2020HK03318A10-2020HK03418A10-2020HK03518A10-2020HK03618A10-2020HK13718A11-2020HK13818A11-2020HK13918A11-2020HK14018A11-2020HK14118A11-2020HK14218A11-2020HK14318A11-2020HK14418A11-2020HK14518A11-2020HM00118A11-2020
- Amount recalled
- N/A
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Amneal Pharmaceuticals recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.