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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

MACLEODS PHARMA USA, INC: Rizatriptan Benzoate Tablets Recalled for Impurity Test Results

Agency Publication Date: October 28, 2021
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Summary

Approximately 792,142 units of Rizatriptan Benzoate (generic Maxalt) tablets are being recalled because testing identified organic impurities that did not meet quality standards. The recall includes various strengths of film-coated and orally disintegrating tablets used to treat migraine symptoms. These prescription medications were distributed nationwide across the United States in blister packs containing 12 or 18 tablets.

Risk

The presence of out-of-specification organic impurities means the drug may contain substances that were not intended to be in the final product, which could potentially affect the safety or effectiveness of the medication over time.

What You Should Do

  1. Check your medication packaging for Rizatriptan Benzoate 10 mg Film Coated Tablets (NDC 33342-088-45 or 33342-088-41) with lot numbers BRJ2112A, BRJ2113A, BRJ2114A, or BRJ2114B and an expiration date of 04/2024.
  2. Check for Rizatriptan Benzoate 5 mg Orally Disintegrating Tablets (NDC 33342-093-41) with lot numbers BRL2102A or BRL2103A and an expiration date of 04/2025.
  3. Check for Rizatriptan Benzoate 10 mg Orally Disintegrating Tablets (NDC 33342-094-41) with lot numbers BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, or BRM2116A and an expiration date of 04/2025.
  4. If your medication matches any of these lot numbers and expiration dates, contact your healthcare provider or pharmacist immediately to discuss continuing your treatment and obtaining a safe replacement.
  5. Return any unused portions of the affected medicine to the pharmacy where you purchased it for a refund.
  6. Contact Macleods Pharma USA, Inc. at their Princeton, NJ office or through your pharmacist for further instructions regarding this voluntary recall.
  7. For additional questions or to report adverse effects, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Contact healthcare provider and return product for refund.

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

Affected Products

Product: Rizatriptan Benzoate Film Coated Tablets, 10 mg (12-count or 18-count)
Model:
NDC 33342-088-45
NDC 33342-088-41
Lot Numbers:
BRJ2112A (Exp 04/2024)
BRJ2113A (Exp 04/2024)
BRJ2114A (Exp 04/2024)
BRJ2114B (Exp 04/2024)
Date Ranges: 04/2024
Product: Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg (12-count)
Model:
NDC 33342-093-41
Lot Numbers:
BRL2102A (Exp 04/2025)
BRL2103A (Exp 04/2025)
Date Ranges: 04/2025
Product: Rizatriptan Benzoate Orally Disintegrating Tablets, 10 mg (18-count)
Model:
NDC 33342-094-41
Lot Numbers:
BRM2111A (Exp 04/2025)
BRM2112A (Exp 04/2025)
BRM2113A (Exp 04/2025)
BRM2114A (Exp 04/2025)
BRM2115A (Exp 04/2025)
BRM2116A (Exp 04/2025)
Date Ranges: 04/2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88872
Status: Resolved
Manufacturer: MACLEODS PHARMA USA, INC
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 3 products (135,082 Blister Packs/2,431,476 tablets; 13,260 Blister Packs/238,680 tablets; 643,800 Blister Packs /888,336 Tablets)
Distributed To: Nationwide

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.