The Recall Desk
ModerateFDA (Drugs)·D-1136-2015·Announced 2015-06-24

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

Dr. Reddy's Laboratories is recalling 5,160 bottles of Divalproex Sodium Extended-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 is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct contamination or acute injury risk.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling 5,160 bottles of Divalproex Sodium Extended-Release Tablets, USP, 500 mg. The affected product is identified by Lot #C308195 with an expiration date of 10/2015. The bottles contain 100 tablets each and are labeled as Rx Only.

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

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
DIVALPROEX SODIUM (DIVALPROEX SODIUM)
Brand
DIVALPROEX SODIUM
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
5,160

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 (2)

  • Lot #C308195
  • exp 10/2015

UPCs (1)

  • 0355111534013

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 →

Related recalls

Same brand · DIVALPROEX SODIUM

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · dissolution failure

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