Bupropion Hydrochloride ER Tablets — Class III drug recall D-1212-2018
Terminated recall by InvaGen Pharmaceuticals, Inc., reported 2018-09-26, distributed nationwide. Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobe
| Recall number | D-1212-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InvaGen Pharmaceuticals, Inc., Hauppauge, NY, United States |
| Recall initiated | 2018-09-06 |
| Classified | 2018-09-25 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2020-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 26,496 bottles |
| Reason classes | specification failure |
| NDC | 68001-0322-05, 69097-0875, 69097-0875-02, 69097-0875-05, 69097-0875-12, 69097-0876, 69097-0876-02, 69097-0876-12 |
Product
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
Reason for recall
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
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-1212-2018. 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.