Class III · Low risk Ongoing
Benzonatate Capsules
Reason Superpotent drug: Assay results were slightly above specification at the time zero point.
Benzonatate Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
What was recalled
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
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- NDC code
- 68382-247-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0325-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Benzonatate recalls
See all
Class I · High risk Terminated
Benzonatate capsules
Reason Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Class III · Low risk Terminated
Benzonatate capsules
Reason Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Class II · Moderate risk Terminated
Benzonatate Capsules
Reason Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Class II · Moderate risk Terminated
Benzonatate Capsules
Reason Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.