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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

Unichem Pharmaceuticals Usa Inc: Divalproex Sodium Delayed Release Tablets Recalled for Cross-Contamination

Agency Publication Date: January 17, 2018
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Summary

Unichem Pharmaceuticals (USA) Inc. is recalling 96,876 bottles of Divalproex Sodium Delayed Release Tablets USP (500 mg), a medication used to treat seizures and bipolar disorder. The recall was initiated because metronidazole powder, an antibiotic, was found inside a bottle of the medication. Consumers should contact their healthcare provider or pharmacist immediately to discuss their treatment and how to obtain a safe replacement.

Risk

The presence of metronidazole powder in a bottle of Divalproex Sodium poses a risk of cross-contamination. Patients may unintentionally ingest an unintended medication, which could lead to adverse drug reactions or interfere with the effectiveness of their prescribed seizure or mood disorder treatment.

What You Should Do

  1. Check your prescription bottles to see if you have Divalproex Sodium Delayed Release Tablets USP, 500 mg (100-count or 30-count bottles) with the National Drug Code (NDC) 29300-140-01.
  2. Locate the lot number on the side of the bottle and check for Lot: ZDPH17040.
  3. If your medication matches this lot number, contact your healthcare provider or pharmacist immediately for guidance on continuing your treatment.
  4. Do not stop taking your prescribed medication without consulting a healthcare professional, as sudden discontinuation of seizure medication can be dangerous.
  5. Return any unused product from the affected lot to your pharmacy for a refund and contact Unichem Pharmaceuticals for further instructions.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Healthcare consultation and pharmacy refund

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

Affected Products

Product: Divalproex Sodium Delayed Release Tablets USP, 500 mg (100-count bottle)
Model:
NDC 29300-140-01
Lot Numbers:
ZDPH17040
Product: Divalproex Sodium Delayed Release Tablets USP, 500 mg (30-count bottle)
Model:
NDC 29300-140-01
Lot Numbers:
ZDPH17040

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78786
Status: Resolved
Manufacturer: Unichem Pharmaceuticals Usa Inc
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 96,876 Bottles of 30s
Distributed To: Nationwide

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 · 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.