Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: Levonorgestrel and Ethinyl Estradiol Tablets Recalled for Incorrect Labeling

Agency Publication Date: October 12, 2018
Share:
Sign in to monitor this recall

Summary

Mylan Pharmaceuticals Inc. is recalling 5,790 cartons (approximately 526,890 tablets) of Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, which is an extended-cycle birth control medication. The recall was initiated because the individual blister packs inside the cartons contain the incorrect product name and NDC (National Drug Code) number. This labeling error could lead to confusion regarding the medication being taken, though the tablets themselves are the correct strength and dosage.

Risk

The incorrect product name and drug identifiers on the internal blister packs may cause patients to take the wrong medication or doubt the authenticity of their prescription, potentially leading to unintended pregnancy or dosing errors if the consumer is confused by the conflicting labels.

What You Should Do

  1. Check your medication packaging for Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg with NDC 0378-7281-53.
  2. Verify if your product belongs to lot number 8508F004A with an expiration date of 02/20 (February 2020).
  3. Inspect the individual blister packs inside the carton to see if the product name or NDC number printed on the blister differs from the outer carton.
  4. Contact your healthcare provider or pharmacist immediately for guidance if you find you have an affected lot or are concerned about your birth control regimen.
  5. Return any unused or incorrectly labeled product to your pharmacy for a refund and to ensure you receive a correctly labeled replacement.
  6. Contact Mylan Pharmaceuticals Inc. at 1-888-723-3332 for further instructions regarding this recall.
  7. For additional questions, 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 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

Affected Products

Product: Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg (3 extended-cycle blister packs containing 91 tablets each)
Model:
NDC 0378-7281-53
Recall #: D-0025-2019
Lot Numbers:
8508F004A (Exp. 02/20)
Date Ranges: Expiration: 02/20

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81221
Status: Resolved
Manufacturer: Mylan Pharmaceuticals Inc.
Sold By: pharmacies
Manufactured In: India
Units Affected: 5,790 cartons (526,890 tablets)
Distributed To: Nationwide
Agency Last Updated: October 15, 2018

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.