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.
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 involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct physical injury or contamination.
Plain-English summary
Zydus Pharmaceuticals USA Inc is recalling Divalproex Sodium Delayed Release Tablets, USP, 250 mg. The affected products are available in 100-count and 500-count bottles and are distributed nationwide.
The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the medication releases its active ingredient at the proper rate and amount in the body. When these specifications are not met, the medication may not work as intended.
Patients and healthcare providers should check their inventory for the specific NDC numbers and lot codes listed in the official recall notice. If the medication is found, it should be returned to the pharmacy or distributor for a replacement or refund. Consumers should not discontinue their medication without consulting their healthcare provider.
The recalled product
- Product
- Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),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
- 115,122
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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