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-1347-2020
- FDA event ID
- 85781
- Recalling firm
- Amneal Pharmaceuticals of New York, Brookhaven, NY
- Manufacturer
- Amneal Pharmaceuticals LLC
- 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 Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10
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?
AM181118AA 10/31/2020 AM181191AA 9/30/2020 AM181192AA 9/30/2020 AM181235AA 9/30/2020 AM181236AA 9/30/2020 AM181237AA 9/30/2020 AM181240AA 9/30/2020 AM181241AA 9/30/2020 AM181242AA 9/30/2020 AM181243AA 9/30/2020 AM181244AA 10/31/2020 AM181268AA 10/31/2020 AM181269AA 10/31/2020 AM181270AA 10/30/2020 AM181271AA 10/31/2020 AM181272AA 10/31/2020 AM181273AA 10/31/2020 AM181274AA 10/31/2020 AM181275AA 10/31/2020 AM181276AA 10/31/2020 AM181277AA 10/31/2020 AM181307AA 10/31/2020 AM181308AA 10/31/2020 AM181309AA 10/31/2020 AM181310AA 10/31/2020 AM181311AA 10/31/2020 AM181313AA 10/31/2020 AM181314AA 10/31/2020 AM181315AA 11/30/2020 AM181316AA 11/30/2020 AM181317AA 12/31/2020 AM181419AA 11/30/2020 AM181420AA 11/30/2020 AM181421AA 11/30/2020 AM181422AA 11/30/2020 AM181423AA 11/30/2020 AM181424AA 11/30/2020 AM181425AA 11/30/2020 AM181430BA 12/31/2020 AM181455AA 12/31/2020 AM181456AA 12/31/2020 AM181457AA 12/31/2020 AM181458AA 12/31/2020 AM181459AA 12/31/2020 AM181460AA 12/31/2020 AM181461AA 12/31/2020 AM181462AA 12/31/2020 AM181463AA 12/31/2020 AM181464AA 12/31/2020 AM181465AA 12/31/2020 AM190054AA 12/31/2020 AM190055AA 12/31/2020 AM190057AA 12/31/2020 AM190058AA 12/31/2020 AM190102AA 12/31/2020 AM190103AA 12/31/2020 AM190104AA 12/31/2020 AM190105AA 12/31/2020 AM190106AA 12/31/2020 AM190107AA 12/31/2020 AM190108AA 12/31/2020 AM190120AA 12/31/2020 AM190633AA 5/31/2021 AM190634AA 5/31/2021 AM190635AA 5/31/2021 AM190636AA 5/31/2021 AM190637AA 5/31/2021 AM190638AA 5/31/2021 AM190640AA 5/31/2021 AM190641AA 5/31/2021 AM190642AA 5/31/2021 AM190664AA 5/31/2021 AM190665AA 5/31/2021 AM190666AA 5/31/2021 AM190667AA 5/31/2021 AM190668AA 5/31/2021 AM190669AA 6/30/2021 AM190670AA 6/30/2021 AM190671AA 6/30/2021 AM190672AA 6/30/2021 AM190714AA 6/30/2021 AM190934A 8/31/2021 AM190991A 8/31/2021 AM190992A 8/31/2021 AM190993A 8/31/2021 AM190994A 8/31/2021 AM191040A 9/30/2021 AM191041A 9/30/2021 AM191083A 9/30/2021 AM191084A 9/30/2021 AM191085A 9/30/2021 AM191091A 9/30/2021 AM191092A 9/30/2021 AM191105A 9/30/2021 AM191106A 10/31/2021 AM191107A 10/31/2021 AM191109A 10/31/2021 AM191186A 10/31/2021 AM191187A 10/31/2021 AM191188A 10/31/2021 AM191189A 10/31/2021 AM191190A 10/31/2021 AM191191A 10/31/2021 AM191192A 10/31/2021 AM191193A 10/31/2021 AM191194A 10/31/2021 AM191195A 10/31/2021 AM191244A 10/31/2021 AM191245A 10/31/2021 AM191246A 10/31/2021 AM191247A 10/31/2021 AM191294A 11/30/2021 AM191295A 11/30/2021 AM191296A 11/30/2021 AM191365A 11/30/2021 AM191366A 11/30/2021 AM191367A 11/30/2021 AM191392A 11/30/2021 AM191393A 11/30/2021 AM191394A 11/30/2021 AM191395A 12/31/2021 AM200001A 12/31/2021 AM200002A 12/31/2021 AM200003A 12/31/2021 AM200004A 12/31/2021 AM200005A 12/31/2021 AM200006A 12/31/2021 AM200045A 12/31/2021 AM200046A 12/31/2021 AM200047A 12/31/2021 AM200048A 12/31/2021 AM200049A 12/31/2021 AM200050A 12/31/2021 AM200051A 12/31/2021 AM200052A 12/31/2021 AM200053A 12/31/2021 AM200081A 12/31/2021 AM200082A 12/31/2021 AM200083 12/31/2021 AM200087A 12/31/2021 AM200088A 12/31/2021 AM200089 12/31/2021 AM200090 12/31/2021 AM200091 12/31/2021 AM200100 1/31/2022 AM200101 1/31/2022 AM200102 1/31/2022 AM200138 1/31/2022 AM200139 1/31/2022 AM200140 1/31/2022 AM200141 1/31/2022 AM200142 1/31/2022 AM200143 1/31/2022 AM200144 1/31/2022 AM200193 1/31/2022 AM200194 1/31/2022 AM200195 1/31/2022 AM200196 1/31/2022 AM200197 1/31/2022 AM200198 1/31/2022 AM200199 1/31/2022 AM200200 1/31/2022 AM200202 1/31/2022 AM200203 1/31/2022 AM200204 1/31/2022 AM200205 1/31/2022 AM200206 1/31/2022 AM200207 1/31/2022 AM200208 1/31/2022 AM200209 1/31/2022 AM200210 1/31/2022 AM200211 1/31/2022 AM200284 2/28/2022 AM200285 2/28/2022 AM200287 2/28/2022 AM200288 2/28/2022 AM200289 2/28/2022 AM200290 2/28/2022 AM200291 2/28/2022 AM200292 2/28/2022
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 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Exenatide Injection, USP, 250 mcg/mL per prefilled pen recalledExenatide | Amneal Pharmaceuticals of New York | Other | Nationwide |
| Drug | CLASS II | Methylergonovine Maleate Tablets, USP, 0.2mg recalledMethylergonovine Maleate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Oseltamivir Phosphate for Oral Suspension 6mg/ml (reconstituted) recalledOseltamivir Phosphate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
Other Metformin recalls
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalled | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalledMetformin Er 500 Mg | Granules Pharmaceuticals | Other | OH |
| Drug | CLASS II | Metformin hydrochloride Extended-Release Tablets, 1000 mg recalled | Teva Pharmaceuticals USA | Nitrosamine Impurity | CA |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | NJ |