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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Jubilant Cadista Pharmaceuticals, Inc.: Drospirenone and Ethinyl Estradiol Tablets Recalled for Failed Dissolution

Agency Publication Date: July 28, 2019
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Summary

Jubilant Cadista Pharmaceuticals is recalling 11,412 cartons of Drospirenone and Ethinyl Estradiol tablets (3 mg/0.02 mg), which is a generic birth control medication. This recall involves 34,236 blister cards because the tablets failed quality testing for dissolution at the 3-month stability point, meaning they may not break down properly in the body. If the medication does not dissolve as designed, the body may not absorb the necessary hormones, which could result in the product being less effective at preventing pregnancy. This recall affects generic versions of Yaz distributed nationwide.

Risk

The failure of the tablets to dissolve correctly means the active hormones may not reach the required levels in a patient's system. This defect poses a significant risk of unintended pregnancy for consumers relying on this medication for contraception.

What You Should Do

  1. Check your medication packaging for the National Drug Code (NDC) 59746-763-43 and lot number 183222 with an expiration date of 11/2020.
  2. If you have an affected blister card, contact your healthcare provider or pharmacist immediately to obtain a replacement and discuss alternative contraceptive methods.
  3. Do not stop taking your current medication until you have a replacement or have consulted a healthcare professional, as an abrupt stop may have other health consequences.
  4. Return any unused product from the affected lot to the pharmacy where you purchased it for a refund.
  5. Contact Jubilant Cadista Pharmaceuticals directly for additional information regarding the return process or product replacement.
  6. For further assistance or to report side effects, 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

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg (Carton of 3 Blister Cards)
Model:
NDC 59746-763-43
Recall #: D-1837-2019
Lot Numbers:
183222 (Exp 11/2020)
Date Ranges: Expiration November 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83408
Status: Resolved
Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.
Sold By: Pharmacies; Healthcare Providers
Manufactured In: Spain, United States
Units Affected: 11,412 cartons/34,236 blister cards/28 tablets each card
Distributed To: Nationwide
Agency Last Updated: August 19, 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 · 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.