The Harvard Drug Group recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only,
The Harvard Drug Group recalls Metformin Hydrochloride Extended-Release Tablets (500mg) due to potential presence of NDMA impurity above safe levels. This recall affects specific lot numbers and distribution channels.
Recall notice
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Contact the company & request your remedy
What happened, in plain English
The Harvard Drug Group is recalling Metformin Hydrochloride Extended-Release Tablets (500mg) because they may contain unsafe levels of NDMA impurity. This could pose health risks, especially for people with certain medical conditions who take this medication. Read more at govinfonow.com/recall/37049-metformin-extended-release-tablets-recall-potential-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37049-metformin-extended-release-tablets-recall-potential-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1360-2020
Cite this page
“Metformin Extended-Release Tablets Recall: Potential NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37049-metformin-extended-release-tablets-recall-potential-ndma-impurity-risk. Based on FDA recall #D-1360-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1360-2020%22&limit=1).
Why it’s dangerous
NDMA is a potential carcinogen that can form in some medications during manufacturing. The presence of NDMA above safe levels in these tablets could increase cancer risk over time, particularly for people who take the medication regularly.
Who’s affected
People who have been prescribed Metformin Hydrochloride Extended-Release Tablets (500mg) by a healthcare provider. Those with kidney issues or taking other medications that interact with Metformin may be at higher risk.
How to tell if you have this one
Check for the product name 'Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons' on the label. Look for the lot number T-02134 and expiration date 09/2020 on the packaging.
- Brand
The Harvard Drug Group- Category
Drug
What to do — step by step
Check Product Details
Verify the product label includes the lot number T-02134 and expiration date 09/2020.
Questions people ask
Is this recall affecting all Metformin products?
No, this recall specifically applies to Metformin Hydrochloride Extended-Release Tablets (500mg) with lot number T-02134 and expiration date 09/2020.
How can I get a refund or replacement?
The recall notice does not specify any remedy or replacement options.
Is there a risk of serious injury from this product?
The recall states potential presence of NDMA impurity above safe levels, which could increase cancer risk over time, but does not mention immediate injury risks.
Contact The Harvard Drug Group
We’ve drafted a message you can send The Harvard Drug Group to request your refund or repair — edit it as you like.
Subject: Recall D-1360-2020 — The Harvard Drug Group The Harvard Drug Group Hello, I own a The Harvard Drug Group that is covered by recall D-1360-2020 from The Harvard Drug Group. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1360-2020 (June 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1360-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.