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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

Apotex Inc.: Drospirenone and Ethinyl Estradiol Tablets Recalled for Misplaced Tablets

Agency Publication Date: March 6, 2019
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Summary

Apotex Inc. is recalling 82,705 cartons of Drospirenone and Ethinyl Estradiol (3 mg/0.03 mg) contraceptive tablets because the birth control pills may be out of sequence or missing from the blister pack. These prescription oral contraceptives were distributed nationwide in the USA in 28-day blister packs. Because the tablets may be in the wrong order or missing entirely, the product may not provide the intended contraceptive protection.

Risk

Incorrect tablet placement or missing pills in a birth control sequence can lead to a failure of the medication to prevent pregnancy, resulting in an unintended pregnancy or other hormonal disruptions.

What You Should Do

  1. Identify your product by checking for Drospirenone and Ethinyl Estradiol Tablets, USP (3 mg/0.03 mg) in 28-count blister packs (NDC 60505-4183-1) or 84-count cartons (NDC 60505-4183-3).
  2. Check the outer carton or blister pack for lot numbers 7DY008A, 7DY009A, 7DY010A, or 7DY011A with an expiration date of 08/2020.
  3. Immediately contact your healthcare provider or pharmacist for guidance if you find your tablets are out of sequence or missing.
  4. Return any unused product to your pharmacy for a refund and contact Apotex Inc. for further instructions regarding the return process.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall reimbursement and guidance.

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

Affected Products

Product: Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg (28 Tablets Blister)
Model:
NDC 60505-4183-1
NDC 60505-4183-3
Lot Numbers:
7DY008A (Exp. 08/2020)
7DY009A (Exp. 08/2020)
7DY010A (Exp. 08/2020)
7DY011A (Exp. 08/2020)
Date Ranges: Exp. 08/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82288
Status: Resolved
Manufacturer: Apotex Inc.
Sold By: pharmacies
Manufactured In: Canada, Oman
Units Affected: 82,705 cartons
Distributed To: Nationwide
Agency Last Updated: March 11, 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 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.