FDA Drug recall D-0289-2015
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only
- FDA Drug
- Class III
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class III recall of BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only by Zydus Pharmaceuticals Usa, citing presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0289-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-09-24 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
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
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Identifiers
| code_info | Lot #: MM8555, Expiry: 09/14; Lot #: MM6604, Expiry: 09/14; Lot #: MM8551, Expiry: 09/14; Lot #: MM8552, Expiry: 09/14;…Lot #: MM8555, Expiry: 09/14; Lot #: MM6604, Expiry: 09/14; Lot #: MM8551, Expiry: 09/14; Lot #: MM8552, Expiry: 09/14; Lot #: MM8553, Expiry: 09/14; Lot #: MM8554, Expiry: 09/14. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0289-2015%22
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