Recalls / Class II
Class IID-0243-2025
Product
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
- Brand name
- Atomoxetine
- Generic name
- Atomoxetine
- Active ingredient
- Atomoxetine Hydrochloride
- Route
- Oral
- NDCs
- 16714-755, 16714-756, 16714-757, 16714-758, 16714-759, 16714-760, 16714-761
- FDA application
- ANDA079019
- Affected lot / code info
- Lot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026.
Why it was recalled
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- Northstar Rx LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 58,416 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-0243-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.