FDA Drug recall D-0618-2018
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corpora…
- FDA Drug
- Class III
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class III recall of buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corpora… by Invagen Pharmaceuticals, citing failed Dissolution Specifications; during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0618-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-03-15 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Invagen Pharmaceuticals |
| Distribution | US |
Product
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03
Reason
Failed Dissolution Specifications; during stability testing
Identifiers
| ndc | 69097-877-02 |
|---|---|
| ndc | 69097-877-03 |
| ndc | 69097-877-07 |
| ndc | 69097-877-12 |
| ndc | 69097-878-02 |
| ndc | 69097-878-03 |
| ndc | 69097-878-07 |
| ndc | 69097-878-12 |
| ndc | 69097-879-02 |
| ndc | 69097-879-03 |
| ndc | 69097-879-07 |
| ndc | 69097-879-12 |
| code_info | Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018 |
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-0618-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.