Nevirapine Extended Release Tablets — Class II drug recall D-0382-2019
Terminated recall by Cipla Limited, reported 2018-12-26, distributed nationwide. Failed Dissolution Specifications.
| Recall number | D-0382-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipla Limited, Vasco Da Gama, India |
| Recall initiated | 2018-12-14 |
| Classified | 2019-01-16 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 4,800 bottles |
| Reason classes | specification failure |
| NDC | 69097-0403-02 |
| Lot numbers | GG80257 |
| Expiration dates | 2019-12 |
Product
Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02
Reason for recall
Failed Dissolution Specifications.
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-0382-2019. 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.