Class II · ModerateActive recall
Lacosamide
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # 17230982, exp. date Apr-25 17230986, exp. date, Apr-25 17231001, exp. date, Apr-25 17240197, exp. date Jan-26 17240198, exp. date Jan-26 17240215, exp. date Jan-26 17240846, exp. date Apr-26 17240847, exp. date Apr-26
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byGlenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 foreign manufacturer
| Brand name | LACOSAMIDE |
| Generic name | LACOSAMIDE |
| Active ingredient(s) | LACOSAMIDE |
| Distributed by / for | Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 |
| NDC | 68462-681-60 |
Show the full FDA record
| Full product label | Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-681-60. |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Distribution | U.S. Nationwide |
| Quantity | N/A |
| Recall initiated | 2025-03-13 |
| Report date | 2025-04-16 |
| Recall completed | — |
| Recall number | D-0321-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Mahwah NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.