Benzonatate Capsules — Class II drug recall D-0299-2015
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2014-12-24, distributed nationwide. Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
| Recall number | D-0299-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2014-11-26 |
| Classified | 2014-12-16 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2017-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 58,920 bottles |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00368382248015 |
| NDC | 68382-0248-01 |
| Lot numbers | 01/16, 03/16, 05/16, MP2137, MP2138, MP2139, MP3614, MP5611, MP5613 |
Product
Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
Reason for recall
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
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-0299-2015. 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.