Reported Dec 31, 2014 · Terminated

Benzonatate Capsules, USP, 100 mg, 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, 100 mg, 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
3100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05
Lot codes and dates
    • Lot #: MP2625
    • MP2626
    • MP2627 Exp 2/16
    • MP4875
    • MP4876
    • MP4877
    • MP4878 Exp 4/16
    • MP6482
    • MP6483
    • MP6484
    • MP6493
    • MP6494 Exp 6/16
Amount recalled
19,536 units

Where it was sold

  • Nationwide

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 22, 2017 · Data as of Sep 19, 6:34 PM UTC

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