CLASS II Drug recall · Reported 24 Dec 2014 · FDA Enforcement Report
Benzonatate Capsules, USP, 200 mg recalled by Zydus Pharmaceuticals USA
Zydus Pharmaceuticals USA is recalling Benzonatate Capsules, USP, 200 mg, distributed nationwide in the US. The recall was initiated on 26 Nov 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-0299-2015
- FDA event ID
- 69911
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Nov 2014
- FDA classified
- 16 Dec 2014
- Reported
- 24 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 26 Nov 2014 | Recall initiated by company | |
| 16 Dec 2014 | Classified by FDA | +20 days |
| 24 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, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Which lots are affected?
Lot #: MP2137, MP2138, MP2139, Exp 01/16; MP3614, Exp 03/16; MP5611, MP5613, Exp 05/16
Where was it sold?
Nationwide and Puerto Rico
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 26 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
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Tablets, USP 32 mg recalledMethylprednisolone | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.25 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.125 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
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 | 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, 100 mg recalled by Zydus Pharmaceuticals USABenzonatate | Zydus Pharmaceuticals USA | Packaging Defects | Nationwide |