FDA Drugs recall ·
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only… recall
- Recall number
- D-0232-2025
- Date
- (initiated January 29, 2025)
- Company / brand
- Glenmark Pharmaceuticals Inc., USA
750 Corporate Dr, Mahwah, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 56,208 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
Why was it recalled?
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Numbers: 19233756, Exp.: 8/2025; 19235111, Exp.: 11/2025; 19242167, Exp.: 5/2026; 19242180, Exp.: 5/2026.
Distribution
Nationwide within the U.S
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0232-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.