Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Zydus Pharmaceuticals USA Inc
Reason for Recall:
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05

Product Codes/Lot Numbers:

Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0325-2015

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