Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77311

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 09, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Strides Pharma INC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0858-2017
Recall number
D-0858-2017
Initiated
May 09, 2017
Classification
Class III
Status
Terminated
Recalling firm
Strides Pharma INC
Quantity
127,517 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.

Code information

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

Distribution pattern

U.S.A. Nationwide