The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1135-2015·Announced 2015-06-24

Dr. Reddy's Recalls Divalproex Sodium Tablets for Dissolution Failure

Dr. Reddy's Laboratories is recalling Divalproex Sodium Extended-Release Tablets because they failed to meet dissolution specifications at the 9-hour time point.

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, and the hazard involves a failure to meet dissolution specifications without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Divalproex Sodium Extended-Release Tablets, USP, 250 mg and 500 mg. The affected products are prescription-only tablets manufactured in India and distributed nationwide. The recall involves specific lots of 100-count and 500-count bottles with expiration dates of 09/2015.

The recall was initiated because the tablets failed to meet dissolution specifications, specifically exceeding the specification at the 9-hour time point. This indicates that the tablets may not release the medication at the intended rate.

Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance on alternative treatment. The affected lots are identified as Lot #C307859 and Lot #C307812.

The recalled product

Product
DIVALPROEX SODIUM (DIVALPROEX SODIUM)
Brand
DIVALPROEX SODIUM
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Drug
Hazard

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 (3)

  • 100 count bottle - Lot #C307859
  • exp 09/2015
  • 500 count bottle - Lot #C307859 and Lot# C307812

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Dr. Reddy's Laboratories, 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 2 products in this recall →

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