FDAClass IIDecember 6, 2023

Indomethacin 25mg Capsules recall: Labeling Error

Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India…

Why was Indomethacin 25mg Capsules recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484; Exp 8/2025 Lot# 19233490; Exp 8/2025

Product
Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India…
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Quantity
37,200 bottles
Distribution
Nationwide
Recall date
December 6, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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