Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Time-Cap Labs Recalled by Marksans Pharma Limited Due to CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above...

Date: October 2, 2020
Company: Marksans Pharma Limited
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Marksans Pharma Limited directly.

Affected Products

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

Quantity: 368,976 bottles

Why Was This Recalled?

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Marksans Pharma Limited

Marksans Pharma Limited has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report