Reported Dec 24, 2014 · Terminated

Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by

Zydus Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by

3 of 3 products

Products covered by this recall
#Product as published
1Cadila Healthcare Ltd, Ahmedabad, India
2Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534
3NDC 68382-248-01, UPC 3 68382 24801 5.
Lot codes and dates
    • Lot #: MP2137
    • MP2138
    • MP2139
    • Exp 01/16
    • MP3614
    • Exp 03/16
    • MP5611
    • MP5613
    • Exp 05/16
Amount recalled
58,920 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 25, 2017 · Data as of Sep 19, 5:51 PM UTC

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