Time-Cap Labs — Class II drug recall D-1356-2020
Terminated recall by Marksans Pharma Limited, reported 2020-07-01, distributed nationwide. CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake leve
| Recall number | D-1356-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Marksans Pharma Limited, Vasco Da Gama, N/A, India |
| Recall initiated | 2020-06-05 |
| Classified | 2020-06-25 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2023-09-07 |
| Distributed | Nationwide (US) |
| Quantity | 11,279 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 49483-0623, 49483-0623-01, 49483-0623-09, 49483-0623-10, 49483-0623-50, 49483-0624, 49483-0624-01, 49483-0624-50 |
| Expiration dates | 2020-12 |
Product
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, 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 Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
Reason for recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1356-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.