Recalls / Class II
Class IID-0346-2025
Product
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01
- Brand name
- Naproxen Sodium
- Generic name
- Naproxen Sodium
- Active ingredient
- Naproxen Sodium
- Route
- Oral
- NDCs
- 68462-178, 68462-188, 68462-189, 68462-190, 68462-179
- FDA application
- ANDA078314
- Affected lot / code info
- Lot # 17231956, exp. date Aug-25
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- N/A
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-03-13
- FDA classified
- 2025-04-08
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0346-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.