Reported May 31, 2017 · Terminated

Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076…

Strides Pharma Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Strides Pharma INC · 2 Tower Center Blvd Ste 1102 · East Brunswick, NJ · 08816-1100

Is this the product you have?

  • Benzonatate capsules, 200 mg, 100-count bottle, Rx only
  • Manufactured byStrides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06
Lot codes and dates
    • 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
Amount recalled
127,517 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 22, 2017 · Data as of Sep 19, 5:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.