Class III · Lower riskRecall completed
APLENZIN¿ (bupropion hydrobromide)
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: a) 13E023P; Exp. 03/16 Lot #: b) 12J063P; Exp. 07/15 12K063P; Exp. 09/15 12K060P; Exp. 07/15 12M073P; Exp. 09/15 13A036P; Exp. 11/15 13B035P; Exp. 11/15 13C046P; Exp. 11/15 13D060P; Exp. 11/15 13E030P; Exp. 03/16 13E031P; Exp. 03/16 13F003P; Exp. 03/16 13K034P; Exp. 03/16 14A001P; Exp. 10/16
Where it was soldNationwide
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
Labeling: Incorrect or Missing Package Insert
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 byValeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7 foreign manufacturer
| Distributed by / for | Valeant Pharmaceuticals North America LLC |
| NDC | 0024-5812-07 |
Show the full FDA record
| Full product label | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7 |
| Recalling firm | Valeant Pharmaceuticals North America LLC |
| Distribution | Nationwide |
| Quantity | 55,650 HDPE bottles |
| Recall initiated | 2014-06-05 |
| Report date | 2014-11-05 |
| Recall completed | 2017-07-27 |
| Recall number | D-0053-2015 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Bridgewater 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.