Shilpa Medicare Imatinib Mesylate Tablets Recall: FDA Class II

Why it was recalled

CGMP Deviations

Product description

Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.

Lot numbers, UPCs & expiration codes

Lot #s: 7S10033B, 7S10033A, 7S10031A, Exp. 02/28/2021.

Where it was sold

Nationwide in the U.S.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0124-2021
Classification: Class II
Status: Terminated
Recall initiated: Dec 8, 2020
FDA report date: Dec 16, 2020
Quantity: 2611 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Shilpa Medicare Limited

Original FDA data

Every field from FDA enforcement report D-0124-2021, exactly as published.

Show all FDA fields

City: Polepally, Jadcherla
Status: Terminated
Country: India
Event ID: 86749
Address: S-20 To S-26, Pharm. Formulation Sez
Address (line 2): Tsiic, Green Industrial Park
Code information: Lot #s: 7S10033B, 7S10033A, 7S10031A, Exp. 02/28/2021.
Report date: Dec 16, 2020
Product type: Drugs
Recall number: D-0124-2021
Classification: Class II
Recalling firm: Shilpa Medicare Limited
Product quantity: 2611 bottles
Termination date: Mar 11, 2022
Reason for recall: CGMP Deviations
Voluntary / mandated: Voluntary: Firm initiated
Product description: Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.
Distribution pattern: Nationwide in the U.S.
Recall initiation date: Dec 8, 2020
Initial firm notification: Letter
Center classification date: Dec 9, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0124-2021, published Dec 16, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Shilpa Medicare Imatinib Mesylate Tablets 100 mg Recall

Summary