Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Recall #: D-0124-2024
Initiated: November 7, 2023

Compiled from official public sources by the publisher. · Updated September 2026

Glenmark Pharmaceuticals Inc., USA recalled Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmac… - a moderate-severity action.

Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmac… was recalled by Glenmark Pharmaceuticals Inc., USA in December 6, 2023. Reason: Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen. Check the official notice for the remedy. Verify recall #D-0124-2024 with the FDA Drug before acting.

The recall

Glenmark Pharmaceuticals Inc., USA issued this moderate-severity FDA Drug recall-Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen.

Moderate
severity level: Class II
classification: December 6, 2023
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0124-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts. Distribution scope (see Distribution below) 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, 1 from FDA Drug - 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

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

Product description

Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.

Reason for recall

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	D-0124-2024
Date reported	December 6, 2023
Date initiated	November 7, 2023
Recalling firm	Glenmark Pharmaceuticals Inc., USA
Firm location	Mahwah, NJ
Affected scope	Not disclosed
Distribution	Nationwide

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-0124-2024) 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? ▼

Why was this product recalled? ▼

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on December 6, 2023. Severity: Moderate. Recall number: D-0124-2024.

Where was the recalled product distributed? ▼

Distribution: Nationwide.

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Drug, reported December 6, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026