Recall: D-0123-2024

Class II - Potentially Harmful

Class IIClassification

2023-11-07Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

Product

Indomethacin 25mg Capsules, USP, 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 68462-406-01

Reason

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.