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

Xiromed LLC: Altavera (Levonorgestrel and Ethinyl Estradiol) Tablets Recalled for Mislabeling

Agency Publication Date: October 9, 2018
Share:
Sign in to monitor this recall

Summary

Xiromed LLC has recalled 40,064 units of Altavera (levonorgestrel and ethinyl estradiol) Tablets, USP 0.15 mg and 0.03 mg, a prescription oral contraceptive. The recall was initiated because the generic name was mislabeled on a packaging component, which may cause confusion for patients regarding their medication. These products were manufactured by Laboratories Leon Farma S.A. in Spain and distributed nationwide across the United States in three-dispenser packs containing 28 tablets each. Consumers should check their packaging for the specific lot numbers and expiration dates included in this recall.

Risk

The mislabeling of the generic name on the packaging can lead to patient confusion or medication errors, potentially resulting in incorrect dosing or the use of an unintended medication.

What You Should Do

  1. Check your Altavera packaging for the following lot numbers and expiration dates: Lot LF11838A (Expiry May 2020), Lot LF12107A (Expiry June 2020), or Lot LF12106A (Expiry June 2020).
  2. Verify if your medication has NDC 70700-116-85 (for the 3-unit dispenser) or NDC 70700-116-84 (for individual units) printed on the label.
  3. If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss alternative options and ensure you maintain your contraceptive schedule.
  4. Return any unused or mislabeled product to your pharmacy for a refund and contact Xiromed LLC for further instructions regarding the return process.
  5. For additional questions or to report any adverse 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

๐Ÿ’ฐFull Refund

Manufacturer refund or replacement via pharmacy

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

Affected Products

Product: Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg (3 tablet dispensers x 28 tablets)
Model:
NDC 70700-116-85
NDC 70700-116-84
Lot Numbers:
LF11838A (Expiry May 2020)
LF12107A (Expiry June 2020)
LF12106A (Expiry June 2020)
Date Ranges: Expiry May 2020, Expiry June 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81044
Status: Resolved
Manufacturer: Xiromed LLC
Manufactured In: Spain, United States
Units Affected: 40064 3x28 units
Distributed To: Nationwide
Agency Last Updated: October 11, 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.