Medications & Supplements/Prescription Drugs

Marksans Pharma Limited: Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

Agency Publication Date: November 3, 2020

Summary

Marksans Pharma Limited is recalling 433,566 bottles of Metformin Hydrochloride Extended-Release Tablets, a prescription medication used to manage blood sugar in patients with type 2 diabetes. The recall includes various sizes of 500 mg and 750 mg tablets sold under the Time-Cap Labs, Inc. brand. This action was taken because testing detected levels of N-Nitrosodimethylamine (NDMA) that exceed acceptable safety limits. Consumers should continue taking their medication but contact their doctor immediately to discuss an alternative treatment, as stopping diabetes medication without a replacement can pose serious health risks.

Risk

NDMA is classified as a probable human carcinogen, meaning long-term exposure above acceptable levels may increase the risk of cancer. While no immediate adverse events have been reported, the levels found in these specific lots exceed the daily intake limit set by the FDA.

What You Should Do

Check your prescription bottle for 'Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP' in either 500 mg or 750 mg strengths.
Verify the National Drug Code (NDC) and Lot Numbers. For 500 mg tablets, affected NDCs are 49483-623-09 (90 count), 49483-623-01 (100 count), 49483-623-50 (500 count), and 49483-623-10 (1000 count) with lot numbers such as E072F, XP8276, J092F, A40001, and others listed through April 2022.
For 750 mg tablets, check for NDC 49483-624-01 (100 count) with lot numbers including M125E, D001F, J002F, 9R9001, 9R0001, and XR0016 through April 2022.
Do NOT stop taking your medication before talking to your healthcare provider or pharmacist, as the risk of uncontrolled diabetes is often greater than the risk from the impurity.
Contact your healthcare provider or pharmacist for guidance on an alternative prescription and instructions on how to return any unused product to the pharmacy for a refund.
Contact Marksans Pharma Limited or the distributor for further information regarding the return process.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

Full Refund

Refund or credit for recalled medication.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP (500 mg, 90 count)

Model:

NDC 49483-623-09

Lot Numbers:

E072F (Oct-20)

E074F (Oct-20)

E076F (Oct-20)

D096F (Nov-20)

H029F (Nov-20)

H031F (Nov-20)

XP8276 (Nov-20)

XP8289 (Nov-20)

L007F (Dec-20)

J022F (Dec-20)

H039F (Dec-20)

J092F (Jan-21)

L055F (Jun-21)

K079F (Jul-21)

A002G (Aug-21)

A003G (Aug-21)

A007G (Aug-21)

A49001 (Nov-21)

A40001 (Dec-21)

A40003 (Dec-21)

A40005 (Dec-21)

A40009 (Feb-22)

A40010 (Mar-22)

XP0036 (Mar-22)

A40013 (Mar-22)

A40015 (Apr-22)

Date Ranges: October 2020 - April 2022

Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP (500 mg, 100 count)

Model:

NDC 49483-623-01

Lot Numbers:

XP8260 (Oct-20)

XP0010 (Dec-21)

XP0016 (Dec-21)

XP0046 (Apr-22)

Date Ranges: October 2020 - April 2022

Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP (500 mg, 500 count)

Model:

NDC 49483-623-50

Lot Numbers:

E037F (Oct-20)

G011F (Oct-20)

F001F (Nov-20)

H041F (Dec-20)

L009F (Dec-20)

K051F (Jun-21)

A115G (Sep-21)

A010G (Sep-21)

A40006 (Jan-22)

A40007 (Jan-22)

A40008 (Jan-22)

A40011 (Mar-22)

A40016 (Apr-22)

A40018 (Apr-22)

Date Ranges: October 2020 - April 2022

Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP (500 mg, 1000 count)

Model:

NDC 49483-623-10

Lot Numbers:

D086F (Oct-20)

G012F (Nov-20)

L008F (Dec-20)

K042F (Feb-21)

M001F (Jul-21)

A009G (Sep-21)

A40002 (Dec-21)

A40004 (Dec-21)

A40012 (Mar-22)

A40014 (Apr-22)

A40017 (Apr-22)

Date Ranges: October 2020 - April 2022

Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP (750 mg, 100 count)

Model:

NDC 49483-624-01

Lot Numbers:

M125E (Oct-20)

D001F (Nov-20)

C084F (Nov-20)

F073F (Jan-21)

E063F (Jan-21)

F072F (Mar-21)

J002F (Apr-21)

J087F (Apr-21)

K080F (Jun-21)

L056F (Jun-21)

M046F (Jul-21)

9R9001 (Oct-21)

9R9002 (Nov-21)

9R0001 (Dec-21)

9R0002 (Dec-21)

9R0003 (Mar-22)

XR0016 (Mar-22)

9R0004 (Mar-22)

9R0005 (Mar-22)

9R0006 (Apr-22)

9R0007 (Apr-22)

Date Ranges: October 2020 - April 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86530

Status: Resolved

Manufacturer: Marksans Pharma Limited

Sold By: Time-Cap Labs, Inc.; Pharmacies

Manufactured In: India

Units Affected: 2 products (a) 64,590 b) 23,834 c) 109,125 d) 27839 bottles; 368,976 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your prescription bottle for 'Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP' in either 500 mg or 750 mg strengths.

Verify the National Drug Code (NDC) and Lot Numbers. For 500 mg tablets, affected NDCs are 49483-623-09 (90 count), 49483-623-01 (100 count), 49483-623-50 (500 count), and 49483-623-10 (1000 count) with lot numbers such as E072F, XP8276, J092F, A40001, and others listed through April 2022.

For 750 mg tablets, check for NDC 49483-624-01 (100 count) with lot numbers including M125E, D001F, J002F, 9R9001, 9R0001, and XR0016 through April 2022.

Do NOT stop taking your medication before talking to your healthcare provider or pharmacist, as the risk of uncontrolled diabetes is often greater than the risk from the impurity.

Contact your healthcare provider or pharmacist for guidance on an alternative prescription and instructions on how to return any unused product to the pharmacy for a refund.

Contact Marksans Pharma Limited or the distributor for further information regarding the return process.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Affected Products

Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP (500 mg, 90 count)

Model:

NDC 49483-623-09

Lot Numbers:

E072F (Oct-20)

E074F (Oct-20)

E076F (Oct-20)

D096F (Nov-20)

H029F (Nov-20)

H031F (Nov-20)

XP8276 (Nov-20)

XP8289 (Nov-20)

L007F (Dec-20)

J022F (Dec-20)

H039F (Dec-20)

J092F (Jan-21)

L055F (Jun-21)

K079F (Jul-21)

A002G (Aug-21)

A003G (Aug-21)

A007G (Aug-21)

A49001 (Nov-21)

A40001 (Dec-21)

A40003 (Dec-21)

A40005 (Dec-21)

A40009 (Feb-22)

A40010 (Mar-22)

XP0036 (Mar-22)

A40013 (Mar-22)

A40015 (Apr-22)

Date Ranges: October 2020 - April 2022

Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP (500 mg, 100 count)

Model:

NDC 49483-623-01

Lot Numbers:

XP8260 (Oct-20)

XP0010 (Dec-21)

XP0016 (Dec-21)

XP0046 (Apr-22)

Date Ranges: October 2020 - April 2022

Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP (500 mg, 500 count)

Model:

NDC 49483-623-50

Lot Numbers:

E037F (Oct-20)

G011F (Oct-20)

F001F (Nov-20)

H041F (Dec-20)

L009F (Dec-20)

K051F (Jun-21)

A115G (Sep-21)

A010G (Sep-21)

A40006 (Jan-22)

A40007 (Jan-22)

A40008 (Jan-22)

A40011 (Mar-22)

A40016 (Apr-22)

A40018 (Apr-22)

Date Ranges: October 2020 - April 2022

Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP (500 mg, 1000 count)

Model:

NDC 49483-623-10

Lot Numbers:

D086F (Oct-20)

G012F (Nov-20)

L008F (Dec-20)

K042F (Feb-21)

M001F (Jul-21)

A009G (Sep-21)

A40002 (Dec-21)

A40004 (Dec-21)

A40012 (Mar-22)

A40014 (Apr-22)

A40017 (Apr-22)

Date Ranges: October 2020 - April 2022

Product: Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP (750 mg, 100 count)

Model:

NDC 49483-624-01

Lot Numbers:

M125E (Oct-20)

D001F (Nov-20)

C084F (Nov-20)

F073F (Jan-21)

E063F (Jan-21)

F072F (Mar-21)

J002F (Apr-21)

J087F (Apr-21)

K080F (Jun-21)

L056F (Jun-21)

M046F (Jul-21)

9R9001 (Oct-21)

9R9002 (Nov-21)

9R0001 (Dec-21)

9R0002 (Dec-21)

9R0003 (Mar-22)

XR0016 (Mar-22)

9R0004 (Mar-22)

9R0005 (Mar-22)

9R0006 (Apr-22)

9R0007 (Apr-22)

Date Ranges: October 2020 - April 2022