Medications & Supplements/Prescription Drugs

Glenmark Aspirin and Dipyridamole Capsules Recalled for Capsule Breakage

Agency Publication Date: July 18, 2022

Summary

Glenmark Pharmaceuticals Inc., USA is recalling approximately 168,936 bottles of Aspirin and Extended-Release Dipyridamole Capsules (25mg/200 mg). The recall was issued because the capsules may break, which means the product fails to meet its quality specifications. These prescription medications were distributed nationwide in 60-count bottles.

Risk

Broken capsules can lead to inconsistent dosing or a reduction in the effectiveness of the medication. No specific injuries or adverse health events have been reported to date regarding this defect.

What You Should Do

This recall affects Aspirin and Extended-Release Dipyridamole Capsules (25mg/200 mg) sold in 60-count bottles under NDC 68462-405-60.
Check your medication bottle for the lot number and expiration date printed on the label. Affected lots include numbers such as 17201639, 17201759, 17202067, 17210696, and 17210092. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Pharmaceuticals Inc., USA for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Aspirin and Extended-Release Dipyridamole Capsules (60-count bottle)

Variants: 25mg/200 mg, Rx Only

Lot Numbers:

17201639 (Exp 08/2022)

17201759 (Exp 09/2022)

17202067 (Exp 10/2022)

17210696 (Exp 02/2023)

17210092 (Exp 11/2022)

17210145 (Exp 12/2022)

17210732 (Exp 02/2023)

17211062 (Exp 04/2023)

17211441 (Exp 05/2023)

17211670 (Exp 06/2023)

17211810 (Exp 07/2023)

17211862 (Exp 08/2023)

17212020 (Exp 08/2023)

17212068 (Exp 08/2023)

17212438 (Exp 10/2023)

17220172 (Exp 12/2023)

17220251 (Exp 12/2023)

NDC:

68462-405-60

Manufactured for Glenmark Pharmaceuticals Inc., USA.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90543

Status: Active

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Pharmacies

Manufactured In: India

Units Affected: 168936 bottles

Distributed To: Nationwide

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

This recall affects Aspirin and Extended-Release Dipyridamole Capsules (25mg/200 mg) sold in 60-count bottles under NDC 68462-405-60.

Check your medication bottle for the lot number and expiration date printed on the label. Affected lots include numbers such as 17201639, 17201759, 17202067, 17210696, and 17210092. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Pharmaceuticals Inc., USA for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Aspirin and Extended-Release Dipyridamole Capsules (60-count bottle)

Variants: 25mg/200 mg, Rx Only

Lot Numbers:

17201639 (Exp 08/2022)

17201759 (Exp 09/2022)

17202067 (Exp 10/2022)

17210696 (Exp 02/2023)

17210092 (Exp 11/2022)

17210145 (Exp 12/2022)

17210732 (Exp 02/2023)

17211062 (Exp 04/2023)

17211441 (Exp 05/2023)

17211670 (Exp 06/2023)

17211810 (Exp 07/2023)

17211862 (Exp 08/2023)

17212020 (Exp 08/2023)

17212068 (Exp 08/2023)

17212438 (Exp 10/2023)

17220172 (Exp 12/2023)

17220251 (Exp 12/2023)

NDC:

68462-405-60

Manufactured for Glenmark Pharmaceuticals Inc., USA.