The FDA announced on November 7, 2023, that Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Naproxen Tablets, USP 250mg due to a labeling mix-up where Indomethacin bottles may be labeled as Naproxen. The agency issued recall number D-0124-2024 for the Class II violation.
How to tell if you have it
- Brand: Glenmark
- Product: Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only
- Manufacturer: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India
- Distributor: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
- NDC: 68462-188-01
- Lot codes: 19231903 (Exp 4/2025), 19231858 (Exp 4/2025), 19231881 (Exp 4/2025), 19233484 (Exp 8/2025), 19233490 (Exp 8/2025)
- Distribution: Nationwide
The hazard
The hazard involves a labeling error where bottles containing Indomethacin are incorrectly labeled as Naproxen. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Glenmark Pharmaceuticals Inc., USA has 54 other recalls on record since November 20, 2017. Recent similar recalls include the Glenmark Azelaic Acid Gel 15% Recall (July 23, 2026) and the Glenmark Alyacen Birth Control Tablets Recall (May 27, 2026). Other recent recalls of similar products include the Sun Pharmaceutical Perampanel 6mg Tablets Recall (June 17, 2026), the American Health Packaging Buprenorphine Tablets Recall (August 19, 2026), and the Fresen Morphine Syringes Recall (August 4, 2026).