FDA Drug recall D-0858-2017
Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by St…
- FDA Drug
- Class III
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class III recall of Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by St… by Strides Pharma, citing failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0858-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-05-09 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Strides Pharma |
| Distribution | US |
Product
Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06
Reason
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Identifiers
| ndc | 64380-712-06 |
|---|---|
| ndc | 64380-712-07 |
| ndc | 64380-713-06 |
| ndc | 64380-713-07 |
| code_info | Lot #: 7225075, 7225076, 7225077, 7225078, 7225079, 7225080 Exp 7/2017; 7225180, 7225181, 7225322, 7225323, Exp 8/2017;…Lot #: 7225075, 7225076, 7225077, 7225078, 7225079, 7225080 Exp 7/2017; 7225180, 7225181, 7225322, 7225323, Exp 8/2017; 7225649A, 7225650A , 7225651A , 7225652A, 7225653A, 7225654A, Exp 9/2017 |
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-0858-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.