Medications & Supplements/Topical Products

Glenmark Mometasone Furoate Topical Solution Recalled for Defective Container

Agency Publication Date: July 1, 2022

Summary

Glenmark Pharmaceuticals Inc., USA has recalled 98,307 packs of Mometasone Furoate Topical Solution USP, 0.1% Lotion due to defective containers. This prescription medication is used to treat skin conditions such as eczema and psoriasis. No injuries or incidents have been reported in connection with this defect.

Risk

A defective container can lead to product leakage, potential contamination, or loss of potency. This may reduce the effectiveness of the medication in treating skin inflammation and itching.

What You Should Do

This recall affects Mometasone Furoate Topical Solution USP, 0.1% Lotion (30 ml and 60 ml bottles) sold under the Glenmark brand.
Check the bottle size and NDC code on your packaging: the 30 ml bottle is NDC 68462-385-37, and the 60 ml bottle is NDC 68462-385-02.
Examine the lot numbers and expiration dates printed on the container label. 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: Mometasone Furoate Topical Solution USP, 0.1% Lotion (30 ml)

Variants: 30 ml, Lotion, Rx only

Lot Numbers:

05201358 (Exp 06/2022)

05210287 (Exp 01/2023)

05210288 (Exp 01/2023)

05211446 (Exp 07/2023)

05211704 (Exp 08/2023)

05211714 (Exp 08/2023)

05212217 (Exp 10/2023)

NDC:

68462-385-37

Manufactured by Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205.

Product: Mometasone Furoate Topical Solution USP, 0.1% Lotion (60 ml)

Variants: 60 ml, Lotion, Rx only

Lot Numbers:

05201358 (Exp 06/2022)

05210287 (Exp 01/2023)

05210288 (Exp 01/2023)

05210424 (Exp 01/2023)

05210425 (Exp 02/2023)

05210435 (Exp 02/2023)

05211427 (Exp 07/2023)

05211439 (Exp 07/2023)

05211445 (Exp 07/2023)

05211723 (Exp 08/2023)

05211731 (Exp 08/2023)

05211850 (Exp 08/2023)

05211864 (Exp 08/2023)

05212226 (Exp 10/2023)

05212250 (Exp 10/2023)

05212261 (Exp 10/2023)

NDC:

68462-385-02

Manufactured by Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90473

Status: Resolved

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 98, 307 packs

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 Mometasone Furoate Topical Solution USP, 0.1% Lotion (30 ml and 60 ml bottles) sold under the Glenmark brand.

Check the bottle size and NDC code on your packaging: the 30 ml bottle is NDC 68462-385-37, and the 60 ml bottle is NDC 68462-385-02.

Examine the lot numbers and expiration dates printed on the container label. 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: Mometasone Furoate Topical Solution USP, 0.1% Lotion (30 ml)

Variants: 30 ml, Lotion, Rx only

Lot Numbers:

05201358 (Exp 06/2022)

05210287 (Exp 01/2023)

05210288 (Exp 01/2023)

05211446 (Exp 07/2023)

05211704 (Exp 08/2023)

05211714 (Exp 08/2023)

05212217 (Exp 10/2023)

NDC:

68462-385-37

Manufactured by Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205.

Product: Mometasone Furoate Topical Solution USP, 0.1% Lotion (60 ml)

Variants: 60 ml, Lotion, Rx only

Lot Numbers:

05201358 (Exp 06/2022)

05210287 (Exp 01/2023)

05210288 (Exp 01/2023)

05210424 (Exp 01/2023)

05210425 (Exp 02/2023)

05210435 (Exp 02/2023)

05211427 (Exp 07/2023)

05211439 (Exp 07/2023)

05211445 (Exp 07/2023)

05211723 (Exp 08/2023)

05211731 (Exp 08/2023)

05211850 (Exp 08/2023)

05211864 (Exp 08/2023)

05212226 (Exp 10/2023)

05212250 (Exp 10/2023)

05212261 (Exp 10/2023)

NDC:

68462-385-02

Manufactured by Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205.