Recalls / Class II
Class IID-0123-2024
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
- Brand name
- Indomethacin
- Generic name
- Indomethacin
- Active ingredient
- Indomethacin
- Route
- Oral
- NDCs
- 68462-302, 68462-406
- FDA application
- ANDA091276
- Affected lot / code info
- 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
Why it was recalled
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 37,200 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-11-07
- FDA classified
- 2023-11-27
- Posted by FDA
- 2023-12-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0123-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.