Time-Cap Labs — Class II drug recall D-0062-2021
Terminated recall by Marksans Pharma Limited, reported 2020-11-11, distributed nationwide. CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
| Recall number | D-0062-2021 |
|---|---|
| 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 | 2020-10-02 |
| Classified | 2020-11-02 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2024-02-21 |
| Distributed | Nationwide (US) |
| Quantity | 368,976 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 |
Product
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
Reason for recall
CGMP Deviations: detection of 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-0062-2021. 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.