Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0617-2017·Announced 2017-04-05

Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed dissolution specifications and long-term stability testing.

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 due to failed dissolution and stability specifications, which is a quality defect that may affect drug efficacy but does not involve reported injuries or high-risk pathogens.

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 tablets were manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and distributed by Zydus Pharmaceuticals in Pennington, New Jersey.

The recall was initiated because the product failed dissolution specifications and 9-month long-term stability testing. A total of 32,628 bottles were distributed nationwide. Specific lot numbers and expiration dates are listed in the recall documentation.

Consumers with these products should contact their healthcare provider or pharmacist for guidance on alternative treatments. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
Manufacturer: Zydus Pharmaceuticals USA Inc
Category: Drug — Anticonvulsant
Hazard: failed-dissolution
stability-failure
Affected units: 32,628

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

a) MR8221
MR8222 exp 7/31/2017
MR10260
exp 9/30/2017
MR10926
exp 10/31/2017
b) MR6187
exp 5/31/2017
MR7302
exp 6/30/2017
MR7768
MR7769
exp 7/31/2017
MR8247
MR8887
MR8892
MR8893 exp 8/31/2017
MR9014
MR10414 exp 9/30/2017
MR10928

Distribution

Distributed nationwide across the United States.

Same manufacturer · Zydus Pharmaceuticals USA Inc

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Same hazard · failed dissolution