Benzonatate Capsules — Class II drug recall D-0325-2015
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2014-12-31, distributed nationwide. Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
| Recall number | D-0325-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2014-12-23 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2017-09-22 |
| Distributed | Nationwide (US) |
| Quantity | 19,536 units |
| Reason classes | packaging |
| NDC | 68382-0091, 68382-0091-01, 68382-0247, 68382-0247-01, 68382-0247-05 |
| Lot numbers | 2/16, 4/16, 6/16, MP2625, MP2626, MP2627, MP4875, MP4876, MP4877, MP4878, MP6482, MP6483, MP6484, MP6493, MP6494 |
Product
Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05
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-0325-2015. 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.