FDA Drug recall D-0230-2018
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc
- FDA Drug
- Class III
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class III recall of bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc by Mylan Pharmaceuticals, citing failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during rout….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0230-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-11-03 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
Reason
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
Identifiers
| code_info | Lot # 3077281, EXP 06-2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0230-2018%22
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