buPROPion HCl Extended-Release Tablets — Class III drug recall D-0619-2018
Terminated recall by InvaGen Pharmaceuticals, Inc., reported 2018-04-11, distributed nationwide. Failed Dissolution Specifications; during stability testing
| Recall number | D-0619-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InvaGen Pharmaceuticals, Inc., Hauppauge, NY, United States |
| Recall initiated | 2018-03-15 |
| Classified | 2018-04-04 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2021-09-15 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 69097-0877, 69097-0877-02, 69097-0877-03, 69097-0877-07, 69097-0877-12, 69097-0878, 69097-0878-02, 69097-0878-03, 69097-0878-07, 69097-0878-12, 69097-0879, 69097-0879-02, 69097-0879-03, 69097-0879-07, 69097-0879-12 |
| Lot numbers | I1606609, I1606610, I1607845, I1607847, I1610639 |
| Expiration dates | 2018-05, 2018-06, 2018-09 |
Product
buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) 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
Reason for recall
Failed Dissolution Specifications; during stability testing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0619-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.