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Lower risk Drug recall · FDA · Published December 30, 2021

Metformin 750mg Extended Release Recall: NDMA Levels Exceed Safe Limits

RemedyRePack recalls Metformin 750mg Extended Release tablets with NDMA levels above safe limits. Consumers should check product lot numbers and contact the company for a replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0366-2022DrugRemedyRePack ›
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Contact the company

Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571
✎ GovInfoNow plain-language explainer

RemedyRePack is recalling Metformin 750 mg Extended Release tablets due to detected N-Nitrosodimethylamine (NDMA) levels exceeding safe limits. This could pose a health risk with long-term use, though the recall does not specify immediate harm. Read more at govinfonow.com/recall/35411-metformin-750mg-extended-release-recall-ndma-levels-exceed-safe-limits.

Source Summary by GovInfoNow · govinfonow.com/recall/35411-metformin-750mg-extended-release-recall-ndma-levels-exceed-safe-limits · Updated August 17, 2026 · FDA enforcement record: FDA #D-0366-2022

Cite this page

“Metformin 750mg Extended Release Recall: NDMA Levels Exceed Safe Limits.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/35411-metformin-750mg-extended-release-recall-ndma-levels-exceed-safe-limits. Based on FDA recall #D-0366-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0366-2022%22&limit=1).

RemedyRepack Inc. voluntarily recalled Metformin 750 mg Extended Release tablets due to CGMP deviations involving N-Nitrosodimethylamine (NDMA) levels exceeding acceptable limits, the FDA said on Dec. 30, 2021.

How to tell if you have it

  • Brand: RemedyRePack
  • Product: Metformin 750 mg Extended Release
  • NDC: 70518-2920-00
  • Lot J0511265-021121, exp. 02/28/2022
  • Lot J0499451-122220, exp. 01/31/2022
  • Lot J0496563-120820, exp. 12/31/2021
  • Lot J0495111-120120, exp. 12/31/2021

The hazard

The recall cites CGMP deviations for the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Context

GovInfoNow's records show RemedyRePack Inc. has 35 other recalls on record since Feb. 18, 2015. Other recent recalls include a Jan. 24, 2025 Carvedilol Tablets recall for N-Nitroso Impurity Risk and an April 22, 2025 Clindamycin Capsules recall due to CGMP Deviations. Similar product recalls by Zydus include Oct. 22, 2025 Clomipramine Capsules for Nitrosamine Impurities Risk and April 29, 2026 Erythromycin Tablets for N-Nitroso-Desmethyl-Erythromycin Risk.

How to tell if you have this one

Check the product label for the lot numbers: J0511265-021121 (exp. 02/28/2022), J0499451-122220 (exp. 01/31/2022), J0496563-120820 (exp. 12/31/2021), or J0495111-120120 (exp. 12/31/2021).

  • Brand
    RemedyRePack
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for the lot numbers listed in the recall: J0511265-021121, J0499451-122220, J0496563-120820, or J0495111-120120.

  2. Contact RemedyRePack

    Reach out to RemedyRePack for a replacement or refund if you have the recalled product.

Where it went and when

Where it was distributed

Distributed in Pennsylvania.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Product was distributed to one direct account in PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Pennsylvania.

Recall timeline

FDA terminated this recall 3 months after the firm started it.

1. Firm started the recall: Dec 30, 202112. FDA classified it Class II: Jan 11, 202223. Published in FDA’s Enforcement Report: Jan 19, 202234. FDA terminated the recall: Mar 28, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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-0366-2022 (December 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0366-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA