Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1041-2017·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 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: failed-dissolution
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.

See all 3 products in this recall →

Same manufacturer · Zydus Pharmaceuticals USA Inc

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