CLASS II Drug recall · Reported 31 Dec 2014 · FDA Enforcement Report
Benzonatate Capsules, USP, 100 mg recalled by Zydus Pharmaceuticals USA
Zydus Pharmaceuticals USA is recalling Benzonatate Capsules, USP, 100 mg, distributed nationwide in the US. The recall was initiated on 23 Dec 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0325-2015
- FDA event ID
- 70101
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Brand
- Benzonatate
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2014
- FDA classified
- 23 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 23 Dec 2014 | Recall initiated by company | |
| 23 Dec 2014 | Classified by FDA | +0 days |
| 31 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Benzonatate Capsules, USP, 100 mg recalled?
Yes. Zydus Pharmaceuticals USA recalled Benzonatate Capsules, USP, 100 mg on 23 Dec 2014. The recall is Class II and its status is Terminated. Recall number D-0325-2015.
Why was it recalled?
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Which lots are affected?
Lot #: MP2625, MP2626, MP2627 Exp 2/16; MP4875, MP4876, MP4877, MP4878 Exp 4/16; MP6482, MP6483, MP6484, MP6493, MP6494 Exp 6/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zydus Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
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| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals (USA) | Other | Nationwide |
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Other Benzonatate recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Benzonatate Capsules, USP, 100 mg x dose cards) recalledBenzonatate | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS I | Benzonatate capsules, 100mg recalled by Calvin Scott & Company | Calvin Scott & Company | Packaging Defects | GA |
| Drug | CLASS III | Benzonatate capsules, 200 mg recalled by Strides PharmaBenzonatate | Strides Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Benzonatate Capsules, USP, 100 mg recalled by American Health PackagingBenzonatate | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Benzonatate Capsules, USP, 200 mg recalled by Zydus Pharmaceuticals USA | Zydus Pharmaceuticals USA | Packaging Defects | Nationwide |