Zydus Recalls Benzonatate Capsules Due to Wet or Leaking Defects
Zydus Pharmaceuticals USA is recalling 19,536 units of Benzonatate capsules because some are wet or leaking. The recall is nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that may cause temporary or medically reversible health consequences. The defect (wet/leaking capsules) is a quality control issue without reported injuries or illnesses, fitting the Moderate severity criteria for minor defects or low-risk contamination.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 19,536 units of Benzonatate Capsules, USP, 100 mg. The recall is due to wet and/or leaking capsules. The affected product is distributed nationwide.
The recalled product is manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ. The affected lots include MP2625, MP2626, MP2627 (Exp 2/16); MP4875, MP4876, MP4877, MP4878 (Exp 4/16); and MP6482, MP6483, MP6484, MP6493, MP6494 (Exp 6/16). The product is available in 100-bottle and 500-bottle packages under NDC 68382-247-01 and NDC 68382-247-05.
Consumers should check their medication for these specific lot numbers and expiration dates. If they have the affected product, they should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- BENZONATATE (BENZONATATE)
- Brand
- BENZONATATE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
- Affected units
- 19,536
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Lot #: MP2625
- MP2626
- MP2627 Exp 2/16
- MP4875
- MP4876
- MP4877
- MP4878 Exp 4/16
- MP6482
- MP6483
- MP6484
- MP6493
- MP6494 Exp 6/16
Distribution
Distributed nationwide across the United States.
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