Reported Jul 1, 2020 · Ongoing
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by:…
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, Rx Only, 100 count bottles
- Distributed byAmneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01
- Lot codes and dates
- HA07419A 1/31/2021 HB00119A 1/31/2021 HB00219A 1/31/2021 HB00319A 1/31/2021;2/28/2021;
HB00419A2/28/2021HB00519A2/28/2021HB00619A2/28/2021HB00719A2/28/2021HB00819A2/28/2021HB00919A2/28/2021HB01019A2/28/2021HB05119A2/28/2021HB05219A2/28/2021HB05319A2/28/2021HB05419A2/28/2021HB05519A2/28/2021HB09519A2/28/2021HB09619A2/28/2021HB09719A2/28/2021HB09819A2/28/2021HB09919A
3/31/2021;HC08219A3/31/2021HC08319A3/31/2021HC08419A3/31/2021HC08519A3/31/2021HC09019A3/31/2021HC09119A3/31/2021HC09219A3/31/2021HC09319A3/31/2021HC09419A
4/30/2021;HD03419B4/30/2021HD03519B4/30/2021HD03619B4/30/2021HD03719B4/30/2021HD03819B4/30/2021HD03919B4/30/2021HD04019B4/30/2021HD04119B4/30/2021HD04219A4/30/2021HD05819A4/30/2021HD05919A4/30/2021HD06019A4/30/2021HD06119A4/30/2021HD06219A4/30/2021HD06319A4/30/2021HD06419A4/30/2021HD09019A4/30/2021HD09119A4/30/2021HD09219A4/30/2021HE01219B4/30/2021HE01319B4/30/2021HE01419B4/30/2021HE01519B
5/31/2021;HE01619A5/31/2021HE01719A5/31/2021HE01819A5/31/2021HE04419A5/31/2021HE04519A5/31/2021HE04619A5/31/2021HE04719A5/31/2021HE04819A5/31/2021HE04919A5/31/2021HE05019A5/31/2021HE05119A5/31/2021HE05219A5/31/2021HE05319A5/31/2021HE07219A5/31/2021HE07319A5/31/2021HE07419A5/31/2021HE07519A5/31/2021HE07619A5/31/2021HF02219A5/31/2021HF02319A
6/30/2021;HF02419A6/30/2021HF02519A6/30/2021HF02619A6/30/2021HF02719A6/30/2021HF02819A6/30/2021HF02919A6/30/2021HF03019A6/30/2021HF03119A6/30/2021HF03219A6/30/2021HF03319A6/30/2021HF05419A
6/30/2020;HF03918A6/30/2020HF04018A6/30/2020HF04118A6/30/2020HF04218A6/30/2020HF04318A6/30/2020HF04418A6/30/2020HF06518A6/30/2020HF06818B6/30/2020HF06918B6/30/2020HF07018B6/30/2020HF07118B6/30/2020HF07218A6/30/2020HF07318A6/30/2020HF07418A6/30/2020HF08318A6/30/2020HF08418A6/30/2020HF08518A
6/30/2021;HF11219A6/30/2021HF11319A6/30/2021HF11419A6/30/2021HF11519A6/30/2021HF11619A6/30/2021HF11719A6/30/2021HF11819A6/30/2021HF11919A6/30/2021HF12019A6/30/2021HG00719A6/30/2021HG00819A6/30/2021HG00919A6/30/2021HG01019A6/30/2021HG01119A6/30/2021HG01219A6/30/2021HG01319A6/30/2021HG01419A
7/31/2021;HG01519A7/31/2021HG01619A7/31/2021HG02919A7/31/2021HG03019A7/31/2021HG03119A7/31/2021HG03219A7/31/2021HG03319A7/31/2021HG03419A7/31/2021HG03519A7/31/2021HG03619A7/31/2021HG03719A7/31/2021HG03819A
8/31/2020;HH08218A8/31/2020HH08318A8/31/2020HH08418A8/31/2020HH08518A8/31/2020HH08618A8/31/2020HH08718A8/31/2020HH08818A8/31/2020HH08918A8/31/2020HH09018A8/31/2020HH09118A8/31/2020HH09218A8/31/2020HH09318A8/31/2020HH09418A8/31/2020HH09518A8/31/2020HH09618A8/31/2020HH11218A8/31/2020HH11318A8/31/2020HH11418A8/31/2020HH11518A
9/30/2020;HH11618A9/30/2020HH11718A9/30/2020HJ04818A9/30/2020HJ04918A9/30/2020HJ08518A
10/31/2020;HJ08618A10/31/2020HJ08718A10/31/2020HJ08818A10/31/2020HJ08918A10/31/2020HJ09018A10/31/2020HJ09118A10/31/2020HK03718A10/31/2020HK03818A10/31/2020HK03918A10/31/2020HK04018A10/31/2020HK04118A10/31/2020HK04218A10/31/2020HK04318A10/31/2020HK04418A10/31/2020HK04518A10/31/2020HK04618A10/31/2020HK09318A10/31/2020HK09418A10/31/2020HK09518A10/31/2020HK09618A10/31/2020HK09718A
12/31/2020;HM00218A12/31/2020HM00318A12/31/2020HM00418A12/31/2020HM00518A12/31/2020HM00618B12/31/2020HM00718B12/31/2020HM00818B12/31/2020HM00918B12/31/2020HM01018B
HM02918A1/31/2021HM03018A1/31/2021HM03218A1/31/2021HM03318A1/31/2021HM03418A1/31/2021HM03518A1/31/2021HM03618A1/31/2021HM03718A1/31/2021HM03818A1/31/2021
- HA07419A 1/31/2021 HB00119A 1/31/2021 HB00219A 1/31/2021 HB00319A 1/31/2021;
- Amount recalled
- 192
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.
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