Medications & Supplements/Prescription Drugs

Glenmark Indomethacin and Naproxen Recalled for Label Mix-Up

Agency Publication Date: November 27, 2023

Summary

Glenmark Pharmaceuticals Inc., USA is recalling 37,200 bottles of Indomethacin 25mg Capsules and Naproxen 250mg Tablets. This recall was initiated because some bottles of Indomethacin may have been incorrectly labeled as Naproxen, which could cause a patient to take the wrong medication. Both products are prescription medications packaged in 100-count bottles.

Risk

A label mix-up poses a significant health risk because patients may unknowingly take Indomethacin, which is a potent nonsteroidal anti-inflammatory drug (NSAID), instead of Naproxen. Taking the wrong medication can lead to serious adverse effects or harmful interactions with other drugs the patient may be using.

What You Should Do

This recall affects 100-count bottles of Indomethacin 25mg Capsules (NDC 68462-406-01) and Naproxen 250mg Tablets (NDC 68462-188-01) manufactured by Glenmark Pharmaceuticals.
Check your medication bottle for lot numbers 19231903, 19231858, or 19231881 with an expiration date of April 2025 (4/2025).
Check your medication bottle for lot numbers 19233484 or 19233490 with an expiration date of August 2025 (8/2025).
If you have health concerns or believe you have taken the wrong medication, contact your healthcare provider or pharmacist immediately.
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 (1-888-SAFEFDA) 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: Indomethacin 25mg Capsules, USP (100-count bottle)

Variants: 25mg, Capsules

Lot Numbers:

19231903 (Exp 4/2025)

19231858 (Exp 4/2025)

19231881 (Exp 4/2025)

19233484 (Exp 8/2025)

19233490 (Exp 8/2025)

NDC:

68462-406-01

Rx Only. Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India.

Product: Naproxen Tablets, USP 250mg (100-count bottle)

Variants: 250mg, Tablets

Lot Numbers:

19231903 (Exp 4/2025)

19231858 (Exp 4/2025)

19231881 (Exp 4/2025)

19233484 (Exp 8/2025)

19233490 (Exp 8/2025)

NDC:

68462-188-01

Rx Only. Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93368

Status: Active

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 37,200 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

Risk

What You Should Do

This recall affects 100-count bottles of Indomethacin 25mg Capsules (NDC 68462-406-01) and Naproxen 250mg Tablets (NDC 68462-188-01) manufactured by Glenmark Pharmaceuticals.

Check your medication bottle for lot numbers 19231903, 19231858, or 19231881 with an expiration date of April 2025 (4/2025).

Check your medication bottle for lot numbers 19233484 or 19233490 with an expiration date of August 2025 (8/2025).

If you have health concerns or believe you have taken the wrong medication, contact your healthcare provider or pharmacist immediately.

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 (1-888-SAFEFDA) 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: Indomethacin 25mg Capsules, USP (100-count bottle)

Variants: 25mg, Capsules

Lot Numbers:

19231903 (Exp 4/2025)

19231858 (Exp 4/2025)

19231881 (Exp 4/2025)

19233484 (Exp 8/2025)

19233490 (Exp 8/2025)

NDC:

68462-406-01

Rx Only. Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India.

Product: Naproxen Tablets, USP 250mg (100-count bottle)

Variants: 250mg, Tablets

Lot Numbers:

19231903 (Exp 4/2025)

19231858 (Exp 4/2025)

19231881 (Exp 4/2025)

19233484 (Exp 8/2025)

19233490 (Exp 8/2025)

NDC:

68462-188-01

Rx Only. Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India.