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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Divalproex Sodium Extended-Release Tablets Recalled for High Humidity Exposure

Agency Publication Date: April 15, 2019
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Summary

Dr. Reddy's Laboratories is recalling approximately 33,958 bottles of Divalproex Sodium (the generic equivalent of Depakote ER) 250 mg tablets because the medication was exposed to humidity levels above 50% during the packaging process. This manufacturing defect could potentially affect the stability and effectiveness of the medication. The recall includes 100-count and 500-count bottles that were distributed to major retailers and pharmacies nationwide. If you use this medication to treat seizures or mood disorders, contact your healthcare provider or pharmacist immediately to discuss a replacement, as stopping this medication suddenly can be dangerous.

Risk

Exposure to excessive humidity during packaging can degrade the chemical stability of extended-release tablets. This may result in the medication not being released into the body at the correct rate, potentially leading to sub-therapeutic levels of the drug and a loss of symptom control.

What You Should Do

  1. Check your prescription bottle for Divalproex Sodium Extended-Release Tablets, USP, 250 mg to see if it matches the affected NDC numbers.
  2. For 100-count bottles (NDC 55111-0533-01), look for lot numbers C802629 (Expiration 03/2020), C805680 (Expiration 07/2020), or C808821 (Expiration 10/2020).
  3. For 500-count bottles (NDC 55111-0533-05), look for lot number C806561 (Expiration 10/2020).
  4. If you identify an affected lot, contact your healthcare provider or pharmacist for guidance on obtaining a replacement. Do not stop taking your medication without consulting a medical professional.
  5. Return any unused product from the recalled lots to the pharmacy where you purchased it for a refund.
  6. Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office for additional information regarding this manufacturing deviation.
  7. For further questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Consult a healthcare professional regarding the safety of your current supply and return affected bottles to the place of purchase.

Affected Products

Product: Divalproex Sodium Extended-Release Tablets, USP, 250 mg (100-count bottle)
Model:
NDC 55111-0533-01
Lot Numbers:
C802629 (Exp. 03/2020)
C805680 (Exp. 07/2020)
C808821 (Exp. 10/2020)
Date Ranges: 03/2020, 07/2020, 10/2020
Product: Divalproex Sodium Extended-Release Tablets, USP, 250 mg (500-count bottle)
Model:
NDC 55111-0533-05
Lot Numbers:
C806561 (Exp. 10/2020)
Date Ranges: 10/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82617
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: major distributors; retailers
Manufactured In: India, United States
Units Affected: 33,958 bottles
Distributed To: Nationwide
Agency Last Updated: May 20, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.