Benzonatate capsules — Class III drug recall D-0858-2017
Terminated recall by Strides Pharma INC, reported 2017-05-31, distributed nationwide. Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
| Recall number | D-0858-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Strides Pharma INC, East Brunswick, NJ, United States |
| Recall initiated | 2017-05-09 |
| Classified | 2017-05-23 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2017-12-22 |
| Distributed | Nationwide (US) |
| Quantity | 127,517 bottles |
| Reason classes | specification failure |
| NDC | 64380-0712, 64380-0712-06, 64380-0712-07, 64380-0713, 64380-0713-06, 64380-0713-07 |
| Lot numbers | 7225075, 7225076, 7225077, 7225078, 7225079, 7225080, 7225180, 7225181, 7225322, 7225323, 7225649A, 7225650A, 7225651A, 7225652A, 7225653A, 7225654A |
| Expiration dates | 2017-07, 2017-08, 2017-09 |
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 for recall
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
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-0858-2017. 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.