Lupin Recalls Metformin ER 500mg Due to NDMA Impurity
Lupin Pharmaceuticals recalls 64,344 bottles of Metformin Hydrochloride Extended-release Tablets 500 mg due to N-Nitrosodimethylamine (NDMA) impurity.
Use caution until it’s fixed
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Contact the company
What happened, in plain English
Lupin Pharmaceuticals Inc. is recalling specific lots of Metformin Hydrochloride Extended-release Tablets USP 500 mg because FDA analysis detected an impurity called N-Nitrosodimethylamine (NDMA) above the acceptable intake level. The recall covers 64,344 bottles distributed throughout the United States. The record does not specify a remedy or action for consumers. Read more at govinfonow.com/recall/36948-lupin-recalls-metformin-er-500mg-due-to-ndma-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/36948-lupin-recalls-metformin-er-500mg-due-to-ndma-impurity · Updated October 11, 2026 · FDA enforcement record: FDA #D-1382-2020
Cite this page
“Lupin Recalls Metformin ER 500mg Due to NDMA Impurity.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36948-lupin-recalls-metformin-er-500mg-due-to-ndma-impurity. Based on FDA recall #D-1382-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1382-2020%22&limit=1).
Why it’s dangerous
The recalled tablets contain N-Nitrosodimethylamine (NDMA), a chemical impurity found above the acceptable intake level established by the FDA. While the record identifies this as a Current Good Manufacturing Practice (CGMP) deviation, it does not explicitly state the specific health risks or injury mechanisms associated with NDMA exposure in this context.
Who’s affected
Patients in the United States who have been prescribed Metformin Hydrochloride Extended-release Tablets USP 500 mg manufactured by Lupin Limited in Goa, India. Individuals possessing bottles with the specific lot numbers listed below are affected.
How to tell if you have this one
Check your medication bottle for the following details: Brand is Lupin; Product is Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only. Look for NDC 68180-338-01 and one of these lot numbers with their corresponding expiration dates: G808201 (Aug-20), G808202 (Aug-20), G808200 (Aug-20), G900935 (Dec-20), G901311 (Dec-20), G900957 (Dec-20), G900958 (Dec-20), G901006 (Dec-20), G904803 (May-21), G904804 (May-21), G906551 (Jul-21), G906552 (Jul-21), G907375 (Aug-21), G908605 (Oct-21), G908604 (Oct-21), G002108 (Jan-22), G002109 (Jan-22), G002559 (Feb-22), or G002560 (Feb-22).
- Brand
Lupin- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Product was distributed throughout the United States.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1382-2020 | Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01; Batch# G808201 Aug-20 G808202 Aug-20 G808200 Aug-20 G900935 Dec-20 G901311 Dec-20 G900957 Dec-20 G900958 Dec-20 G901006 Dec-20 G904803 May-21 G904804 May-21 G906551 Jul-21 G906552 Jul-21 G907375 Aug-21 G908605 Oct-21 G908604 Oct-21 G002108 Jan-22 G002109 Jan-22 G002559 Feb-22 G002560 Feb-22 | 64,344 bottles | 68180-338-01, 68180-338-02, 68180-338-03, 68180-339-09, 68180-339-01, 68180-339-02 |
| D-1383-2020 | Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09; Batch # G807093 Jul-20 G807147 Jul-20 G807208 Jul-20 G807479 Jul-20 G807480 Jul-20 G807830 Jul-20 G807092 Jul-20 G809471 Jul-20 G808155 Aug-20 G808074 Aug-20 G808115 Aug-20 G900231 Nov-20 G900232 Nov-20 G903277 Mar-21 G903278 Mar-21 G903279 Mar-21 G903280 Mar-21 G903281 Mar-21 G903818 Apr-21 G904048 Apr-21 G904164 Apr-21 G906548 Jul-21 G907239 Aug-21 G907255 Aug-21 G907256 Aug-21 G907263 Aug-21 G001802 Jan-22 G001804 Jan-22 G001803 Jan-22 G001805 Jan-22 G001806 Jan-22 G001807 Jan-22 G001808 Jan-22 G808154 Aug-20 G900227 Nov-20 G900228 Nov-20 G900229 Nov-20 G900230 Nov-20 G906549 Jul-21 G906550 Jul-21 G906547 Jul-21 G907279 Aug-21 G907364 Aug-21 G001809 Jan-22 G001801 Jan-22 G002563 Feb-22 G002564 Feb-22 | 95,886 bottles | 68180-338-01, 68180-338-02, 68180-338-03, 68180-339-09, 68180-339-01, 68180-339-02 |
| D-1384-2020 | Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07; Batch # G808293 Aug-20 G808284 Aug-20 G808285 Aug-20 G808343 Aug-20 G901201 Dec-20 G901202 Dec-20 G906915 Jul-21 G906913 Jul-21 G906914 Jul-21 G002135 Jan-22 G002849 Feb-22 | 59,568 bottles | 68180-336-07, 68180-336-02, 68180-336-01, 68180-337-07, 68180-337-01, 68180-337-02 |
| D-1385-2020 | Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07; Batch # G807619 Jul-20 G807620 Jul-20 G807733 Jul-20 G807734 Jul-20 G807735 Jul-20 G807445 Jul-20 G807617 Jul-20 G807618 Jul-20 G808042 Jul-20 G808043 Jul-20 G807349 Jul-20 G807350 Jul-20 G807444 Jul-20 G807507 Jul-20 G807508 Jul-20 G807314 Jul-20 G807316 Jul-20 G807325 Jul-20 G807348 Jul-20 G807616 Jul-20 G807312 Jul-20 G807313 Jul-20 G807315 Jul-20 G808374 Aug-20 G808427 Aug-20 G808373 Aug-20 G808426 Aug-20 G900057 Oct-20 G900058 Oct-20 G900059 Oct-20 G900060 Oct-20 G900061 Oct-20 G900062 Oct-20 G900106 Oct-20 G900140 Oct-20 G900141 Oct-20 G900152 Oct-20 G809596 Oct-20 G809598 Oct-20 G810182 Oct-20 G810183 Oct-20 G810184 Oct-20 G810185 Oct-20 G810186 Oct-20 G810187 Oct-20 G810188 Oct-20 G810189 Oct-20 G809554 Oct-20 G809556 Oct-20 G809557 Oct-20 G809558 Oct-20 G809559 Oct-20 G809548 Oct-20 G809549 Oct-20 G809550 Oct-20 G809551 Oct-20 G809552 Oct-20 G809553 Oct-20 G809555 Oct-20 G901004 Dec-20 G901005 Dec-20 G901053 Dec-20 G901002 Dec-20 G901003 Dec-20 G903182 Mar-21 G903183 Mar-21 G903236 Mar-21 G903237 Mar-21 G903238 Mar-21 G903155 Mar-21 G903156 Mar-21 G903157 Mar-21 G903158 Mar-21 G903159 Mar-21 G903178 Mar-21 G903179 Mar-21 G903180 Mar-21 G903181 Mar-21 G903239 Mar-21 G001837 Jan-22 G001860 Jan-22 G001861 Jan-22 G001905 Jan-22 G001933 Jan-22 G001934 Jan-22 G001763 Jan-22 G001764 Jan-22 G001765 Jan-22 G001766 Jan-22 G001767 Jan-22 G001795 Jan-22 G001836 Jan-22 | 273,060 bottles | 68180-336-07, 68180-336-02, 68180-336-01, 68180-337-07, 68180-337-01, 68180-337-02 |
What to do — step by step
Check Your Medication
Verify if your bottle matches the NDC 68180-338-01 and one of the listed lot numbers with their specific expiration dates.
Contact Your Pharmacist
Since the remedy is not stated in this record, consult your healthcare provider or pharmacist for guidance on what to do next.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Lupin recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1382-2020 (July 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1382-2020 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.