Class II · ModerateActive recall
amneal Metformin Hydrochloride Extended-Release Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberHA01320A 1/31/2021 HA01420A 1/31/2021 HA06820A 1/31/2021 HB03620A 1/31/2021 HB03720A 1/31/2021 HB03820A 1/31/2021 HB03920A 1/31/2021 HB04020A 1/31/2021 HB04120A 1/31/2021 HB04220A 1/31/2021 HB04320A 2/28/2021 HB04420A 1/31/2021 HB04520A 2/28/2021 HB05020A 2/28/2021 HB05120A 2/28/2021 HB05220A 2/28/2021 HB05320A 2/28/2021 HB05420A 2/28/2021 HB05520A 2/28/2021 HB05620A 2/28/2021 HB07020A 2/28/2021 HB07120A 2/28/2021 HB07220A 2/28/2021 HB07320A 2/28/2021 HB07520A 2/28/2021 HB07620A 2/28/2021 HB07720A 2/28/2021 HB07820A 2/28/2021 HB07920A 2/28/2021 HB08020A 2/28/2021 HB08220A 2/28/2021 HF05519A 6/30/2020 HF05619A 6/30/2020 HF05719A 6/30/2020 HF05819A 6/30/2020 HF05919A 6/30/2020 HF06019A 6/30/2020 HF06119A 6/30/2020 HF06219A 6/30/2020 HF06319A 6/30/2020 HF07719A 6/30/2020 HF07819A 6/30/2020 HF07919A 6/30/2020 HF08019A 6/30/2020 HF08119A 6/30/2020 HF08219A 6/30/2020 HF08319A 6/30/2020 HF08419A 6/30/2020 HF08519A 6/30/2020 HF08619A 6/30/2020 HF10119A 6/30/2020 HF10219A 6/30/2020 HF10319A 6/30/2020 HF10419A 6/30/2020 HF10519A 6/30/2020 HF10619A 6/30/2020 HF10719A 6/30/2020 HF10819A 6/30/2020 HF10919A 6/30/2020 HF11019A 6/30/2020 HF11119A 6/30/2020 HG07219A 7/31/2020 HG07319A 7/31/2020 HG07419A 7/31/2020 HG07519A 7/31/2020 HG07619A 7/31/2020 HG07719A 7/31/2020 HG07819A 7/31/2020 HG07919A 7/31/2020 HG08019A 7/31/2020 HG08119A 7/31/2020 HH00619A 7/31/2020 HH00719A 7/31/2020 HH00819A 7/31/2020 HH00919A 7/31/2020 HH01019A 7/31/2020 HH01119A 8/31/2020 HH01219A 8/31/2020 HH01319A 8/31/2020 HH01419A 8/31/2020 HH01519A 8/31/2020 HH07319A 8/31/2020 HH07419A 8/31/2020 HH07519A 8/31/2020 HH07619A 8/31/2020 HH07719A 8/31/2020 HH07819A 8/31/2020 HH07919A 8/31/2020 HH08019A 8/31/2020 HH08119A 8/31/2020 HH08219A 8/31/2020 HH11119A 10/31/2020 HH11219A 10/31/2020 HH11319A 10/31/2020 HH11419A 10/31/2020 HH11519A 10/31/2020 HH11619A 10/31/2020 HH11719A 10/31/2020 HH11819A 10/31/2020 HH11919A 10/31/2020 HH12019A 10/31/2020 HH12119A 10/31/2020 HH12219A 10/31/2020 HH12319A 10/31/2020 HH12419A 10/31/2020 HH12519A 10/31/2020 HH12619A 10/31/2020 HH12719A 10/31/2020 HH12819A 10/31/2020 HH12919A 10/31/2020 HH13019A 10/31/2020 HL00119A 10/31/2020 HL00219A 11/30/2020 HL00319A 11/30/2020 HL00419A 11/30/2020 HL00519A 11/30/2020 HL00619A 11/30/2020 HL00719A 11/30/2020 HL00819A 11/30/2020 HL00919A 11/30/2020 HL01019A 11/30/2020
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 |
| NDC | 53746-0178- |
Show the full FDA record
| Full product label | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC |
| Distribution | Nationwide |
| Quantity | N/A |
| Recall initiated | 2020-05-29 |
| Report date | 2020-07-01 |
| Recall completed | — |
| Recall number | D-1350-2020 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Brookhaven NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.