Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications
Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, and the hazard involves failed dissolution specifications without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zydus Pharmaceuticals USA Inc is recalling Divalproex Sodium Delayed Release Tablets, USP, 500 mg. The affected products are available in 100-count and 500-count bottles and are prescription-only. The recall was initiated because the tablets failed to meet dissolution specifications.
The recall covers 108,726 HDPE bottles distributed nationwide. The products were manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and distributed by Zydus Pharmaceuticals in Pennington, NJ. Specific lot numbers and expiration dates are listed in the recall documentation.
Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or healthcare provider for guidance on alternative treatment options.
The recalled product
- Product
- Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 108,726
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Zydus Pharmaceuticals USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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