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 typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The failure to meet dissolution specifications is a quality issue that may affect drug efficacy but is not associated with immediate severe injury or death in this context.
Plain-English summary
Zydus Pharmaceuticals USA Inc is recalling Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottles. The product is manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and distributed by Zydus Pharmaceuticals in Pennington, NJ. The recall is due to the tablets failing to meet dissolution specifications.
The affected product is identified by NDC 68382-031-01. The recall includes 108,096 HDPE bottles distributed nationwide. Specific lot numbers and expiration dates are listed in the official recall notice, including lots MR6317, MR6318, MR6319, MR5361, MR9007, MR10000, MR10923, MR10924, MR10925, MR11554, MR11555, and MS1359.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or distributor for credit. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 108,096
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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