Paroxetine Tablets USP — Class II drug recall D-0101-2018
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2017-12-06, distributed nationwide. Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
| Recall number | D-0101-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2017-11-20 |
| Classified | 2017-11-30 |
| Reported by FDA | 2017-12-06 |
| Terminated | 2020-09-01 |
| Distributed | Nationwide (US) |
| Quantity | 19,812 bottles |
| NDC | 68382-0001, 68382-0001-01, 68382-0001-05, 68382-0001-06, 68382-0001-10, 68382-0001-16, 68382-0097, 68382-0097-01, 68382-0097-05, 68382-0097-06, 68382-0097-10, 68382-0097-16, 68382-0098, 68382-0098-01, 68382-0098-05, 68382-0098-06, 68382-0098-10, 68382-0098-16, 68382-0099, 68382-0099-01, 68382-0099-05, 68382-0099-06, 68382-0099-10, 68382-0099-16 |
| Expiration dates | 2019-04-20 |
Product
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
Reason for recall
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
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-0101-2018. 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.