Recalls / Class II
Class IID-0237-2025
Product
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
- Brand name
- Atomoxetine
- Generic name
- Atomoxetine
- Active ingredient
- Atomoxetine Hydrochloride
- Route
- Oral
- NDCs
- 68462-265, 68462-266, 68462-267, 68462-268, 68462-269, 68462-270, 68462-271
- FDA application
- ANDA079019
- Affected lot / code info
- Lot Numbers: 19234955, 19234956, Exp.: 11/2025; 19240971, Exp.: 2/2026; 19241864, Exp.: 4/2026.
Why it was recalled
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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
- 39,168 bottles
- Distribution pattern
- Nationwide within the U.S
Timeline
- Recall initiated
- 2025-01-29
- FDA classified
- 2025-02-20
- Posted by FDA
- 2025-02-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0237-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.