Zydus Recalls Risperidone Tablets Due to Impurity Failure
Zydus Pharmaceuticals is recalling 9,504 bottles of 2 mg risperidone tablets because they failed impurity specifications. The affected lot is MP4967.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 III, which is defined as unlikely to cause adverse health consequences. The hazard is a failed impurity specification without reported injuries or illnesses.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 9,504 bottles of risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles. The product is distributed under NDC 68382-156-06 and was manufactured by Cadila Healthcare Ltd. in Ahmedabad, India.
The recall was initiated because the product failed impurities/degradation specifications, specifically being out of specification for a known degradant. The affected lot number is MP4967, with an expiry date of 04/2016.
The product was distributed nationwide in the United States, including Puerto Rico. Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if it matches the recall details.
The recalled product
- Product
- risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 9,504
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 (2)
- Lot #: MP4967
- Expiry: 04/2016.
Distribution
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