Drug recall D-0232-2025
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.
Reason for recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots and codes
Lot Numbers: 19233756, Exp.: 8/2025; 19235111, Exp.: 11/2025; 19242167, Exp.: 5/2026; 19242180, Exp.: 5/2026.
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 56,208 bottles
- Distribution
- Nationwide within the U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 29, 2025
Related products
- Atomoxetine – drug information
- NDC 68462-267 Atomoxetine · Atomoxetine Hydrochloride 25 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-266 Atomoxetine · Atomoxetine Hydrochloride 18 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-269 Atomoxetine · Atomoxetine Hydrochloride 60 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-270 Atomoxetine · Atomoxetine Hydrochloride 80 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-271 Atomoxetine · Atomoxetine Hydrochloride 100 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-268 Atomoxetine · Atomoxetine Hydrochloride 40 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-265 Atomoxetine · Atomoxetine Hydrochloride 10 mg/1 · Glenmark Pharmaceuticals Inc., USA