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FDA Drug recall · Reported July 13, 2022

Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.

Defective Container

Recall #
D-1173-2022
Affected scope
98, 307 packs
Initiated
June 16, 2022
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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Glenmark Pharmaceuticals Inc., USA recalled Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37… - a low-severity action.

Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37… was recalled by Glenmark Pharmaceuticals Inc., USA in July 13, 2022. Reason: Defective Container. Check the official notice for the remedy. Verify recall #D-1173-2022 with the FDA Drug before acting.

The recall

Glenmark Pharmaceuticals Inc., USA issued this low-severity FDA Drug recall-Defective Container.

Low
severity level
Class III
classification
July 13, 2022
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1173-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-1173-2022) was formally reported on July 13, 2022, with the manufacturer initiating the action on June 16, 2022. It is classified under Low severity (Class III), with a current status of Terminated. Glenmark Pharmaceuticals Inc., USA is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 98, 307 packs.

The documented reason for this recall is: Defective Container Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,731 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 146
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Low

Affected scope

98, 307 packs

Related Recalls

6

0 from same agency

Product description

Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.

Reason for recall

Defective Container

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number D-1173-2022
Date reported July 13, 2022
Date initiated June 16, 2022
Recalling firm Glenmark Pharmaceuticals Inc., USA
Firm location Mahwah, NJ
Affected scope 98, 307 packs
Distribution Nationwide in the USA

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-1173-2022) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 98, 307 packs.
Why was this product recalled?
Defective Container
Which agency issued this recall?
This recall was issued by the FDA Drug on July 13, 2022. Severity: Low. Recall number: D-1173-2022.
Where was the recalled product distributed?
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-1173-2022) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 13, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.