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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

Lupin Pharmaceuticals Inc.: Tri-Lo-Marzia Birth Control Recalled for Manufacturing Specification Deviations

Agency Publication Date: January 16, 2020
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Summary

Lupin Pharmaceuticals Inc. is recalling 34,080 boxes of Tri-Lo-Marzia (norgestimate and ethinyl estradiol) birth control tablets. This recall was initiated after a review of test data revealed that the ingredients in the medication blend were not uniform, which can affect the consistency of the tablets produced from that batch. The affected products were distributed nationwide in the United States in cartons containing three 28-tablet wallets each.

Risk

The lack of blend uniformity means that individual tablets may contain more or less of the active hormone ingredients than intended. This could potentially lead to decreased effectiveness of the birth control or an increased risk of side effects.

What You Should Do

  1. Check your medication packaging for Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP) in the 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg strengths.
  2. Verify if your medication is part of the affected batch by looking for Lot # L800498 with an expiration date of February 2020. This lot was distributed in cartons containing three 28-tablet wallets (NDC 68180-837-13) or individual 28-tablet wallets (NDC 68180-837-11).
  3. Contact your healthcare provider or pharmacist immediately to discuss using an alternative form of birth control and to obtain a replacement prescription.
  4. Return any unused portions of the recalled medication to your pharmacy for a refund and contact Lupin Pharmaceuticals Inc. at their Baltimore, MD headquarters for further instructions.
  5. For additional information or to report concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull 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: Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg (3 x 28-count wallets)
Model:
NDC 68180-837-13
NDC 68180-837-11
Lot Numbers:
L800498 (Exp February 2020)
Date Ranges: February 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84674
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 34,080 boxes (3 wallets per carton, 80 cartons per box)
Distributed To: Nationwide
Agency Last Updated: January 18, 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 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.