Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1042-2017·Announced 2017-08-09

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, 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: failed-dissolution
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.

See all 3 products in this recall →

Same manufacturer · Zydus Pharmaceuticals USA Inc

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