BENZONATATE Capsules — Class III drug recall D-0289-2015
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2014-12-10, distributed nationwide. Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
| Recall number | D-0289-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2014-09-24 |
| Classified | 2014-12-03 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2017-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 63,648 bottles |
| NDC | 68382-0248-01 |
| Lot numbers | 09/14, MM6604, MM8551, MM8552, MM8553, MM8554, MM8555 |
Product
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01
Reason for recall
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg 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-0289-2015. 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.