Marksans Pharma Limited recalls Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100
Marksans Pharma Limited recalls Time-Cap Metformin Hydrochloride Extended-Release Tablets (500mg) due to N-Nitrosodimethylamine (NDMA) impurity exceeding safe levels. Consumers should stop using affected batches.
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CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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What happened, in plain English
Marksans Pharma Limited is recalling Time-Cap Metformin Hydrochloride Extended-Release Tablets (500mg) because they contain unsafe levels of N-Nitrosodimethylamine (NDMA). This impurity could pose health risks if taken regularly, so affected consumers should stop using the product immediately. Read more at govinfonow.com/recall/36754-time-cap-metformin-extended-release-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36754-time-cap-metformin-extended-release-tablets-recall-ndma-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0061-2021
Cite this page
“Time-Cap Metformin Extended-Release Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36754-time-cap-metformin-extended-release-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-0061-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0061-2021%22&limit=1).
Why it’s dangerous
The medication contains N-Nitrosodimethylamine (NDMA), a chemical that can form in some drugs during manufacturing. High levels of NDMA have been linked to potential liver damage and cancer risk. The impurity was detected above the acceptable intake level in these specific batches.
Who’s affected
People who have purchased Time-Cap Metformin Hydrochloride Extended-Release Tablets (500mg) from pharmacies or doctors. Those with diabetes who take this medication are most at risk.
How to tell if you have this one
Check the product label for the manufacturer 'Time-Cap Labs, Inc.' and the NDC codes: 49483-623-09 (90 count), 49483-623-01 (100 count), 49483-623-50 (500 count), or 49483-623-10 (1000 count). The product is prescription-only and sold in bottles with specific production dates.
- Brand
Marksans Pharma Limited- Category
Drug
All 2 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
Nationwide- NDC
49483-623-09, 49483-623-01, 49483-623-50, 49483-623-10, 49483-624-01, 49483-624-50
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0061-2021 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50; a) 90 count: E072F, E074F, E076F Oct-20; D096F, H029F, H031F,XP8276, XP8289 Nov-20; L007F, J022F, H039F, Dec-20; J092F Jan-21; L055F Jun-21; K079F Jul-21; A002G, A003G, A007G Aug-21; A49001 Nov-21; A40001, A40003, A40005 Dec-21; A40009 Feb-22; A40010, XP0036, A40013 Mar-22; A40015 Apr-22 b) 100 count: XP8260 Oct-20; XP0010, XP0016 Dec-21; XP0046 Apr-22; c) 500 count: E037F, G011F Oct-20; F001F Nov-20; H041F, L009F Dec-20; K051F Jun-21; A115G, A010G Sep-21; A40006, A40007, A40008 Jan-22; A40011 Mar-22; A40016, A40018 Apr-22; d) 1000 count: D086F Oct-20; G012F Nov-20; L008F Dec-20; K042F Feb-21; M001F Jul-21; A009G Sep-21; A40002, A40004 Dec-21; A40012 Mar-22, A40014, A40017 Apr-22 | a) 64,590 b) 23,834 c) 109,125 d) 27839 bottles |
| D-0062-2021 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01; M125E Oct-20; D001F, C084F Nov-20; F073F, E063F Jan-21; F072F Mar-21; J002F, J087F Apr-21; K080F, L056F Jun 21; M046F, Jul-21; 9R9001, Oct-21; 9R9002, Nov-21; 9R0001, 9R0002 Dec-21; 9R0003, XR0016, 9R0004, 9R0005 Mar-22; 9R0006, 9R0007 Apr-22 | 368,976 bottles |
What to do — step by step
Stop Using Product Now
Immediately stop using any affected Time-Cap Metformin Hydrochloride Extended-Release Tablets (500mg) as they contain unsafe levels of NDMA impurity.
Questions people ask
Why is this medication being recalled?
The medication contains N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level, which could pose health risks including potential liver damage and cancer.
What specific products are affected?
Time-Cap Metformin Hydrochloride Extended-Release Tablets (500mg) with NDC codes 49483-623-09 (90 count), 49483-623-01 (100 count), 49483-623-50 (500 count), or 49483-623-10 (1000 count).
How can I check if my product is affected?
Check the product label for the NDC codes listed above. The product is prescription-only and sold in bottles with specific production dates.
Contact Marksans Pharma Limited
We’ve drafted a message you can send Marksans Pharma Limited to request your refund or repair — edit it as you like.
Subject: Recall D-0061-2021 — Marksans Pharma Limited Marksans Pharma Limited Hello, I own a Marksans Pharma Limited that is covered by recall D-0061-2021 from Marksans Pharma Limited. 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-0061-2021 (October 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0061-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.