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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Jubilant Cadista Pharmaceuticals, Inc.: Lamotrigine Tablets Recalled Due to Foreign Silica Granules

Agency Publication Date: May 28, 2020
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Summary

Jubilant Cadista Pharmaceuticals, Inc. has recalled approximately 1,313,333 Lamotrigine (generic Lamictal) 150 mg tablets. This recall was initiated because foreign substances, visually consistent with silica granules from desiccant packs used during storage, were found in the bulk product. These tablets were shipped in bulk containers for repackaging and may have reached consumers through prescriptions filled after the distribution in Tennessee. If you have been prescribed this medication, please consult your healthcare provider or pharmacist regarding your supply.

Risk

The presence of foreign silica granules in the medication poses a risk of choking or irritation if swallowed. While the risk is considered low, consuming foreign materials not intended for medicinal use can cause physical discomfort or interfere with the proper dosage of the drug.

What You Should Do

  1. Check your medication bottle for Lamotrigine Tablets, USP, 150 mg with NDC number 59746-247-97.
  2. Identify if your prescription was filled from Lot #s 19P0437 or 19P0438 with an expiration date of 09/30/2021. You may need to call your pharmacy to confirm if your specific bottle came from these affected bulk lots.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you believe you have the affected medication. Do not stop taking your medication until you have a replacement, as abruptly stopping Lamotrigine can cause serious health issues.
  4. Return any unused or affected product to your pharmacy to receive a refund and to ensure the product is disposed of correctly.
  5. Contact Jubilant Cadista Pharmaceuticals, Inc. directly at their Salisbury, Maryland facility for further instructions regarding this recall.
  6. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Return to pharmacy for refund and consultation.

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

Affected Products

Product: Lamotrigine Tablets, USP, 150 mg (20,000-count bulk container)
Model:
NDC 59746-247-97
Recall #: D-1281-2020
Lot Numbers:
19P0437 (Exp. 09/30/2021)
19P0438 (Exp. 09/30/2021)
Date Ranges: Expiration Date: 09/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85752
Status: Resolved
Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.
Sold By: AvKare Inc.; Pharmacies
Manufactured In: United States
Units Affected: 1,313,333 tablets
Distributed To: Tennessee
Agency Last Updated: May 29, 2020

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.