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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.: Birth Control Tablets Recalled for Failed Content Uniformity Specifications

Agency Publication Date: March 12, 2020
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Summary

Lupin Pharmaceuticals Inc. has recalled 11,609 cartons of Bekyree (desogestrel and ethinyl estradiol) and Levonorgestrel and Ethinyl Estradiol tablets due to testing results that showed inconsistent levels of the active drug ingredients. This recall includes 1,712 cartons of Bekyree and 9,897 cartons of Levonorgestrel and Ethinyl Estradiol combination tablets. These prescription birth control medications were distributed nationwide across the United States and Puerto Rico. Consumers are advised to consult their healthcare provider regarding these specific lots as the product may not contain the correct medication dosage required for effectiveness.

Risk

The recalled tablets failed content and blend uniformity tests, meaning the active ingredients may not be distributed evenly across the tablets. This could result in a consumer receiving a dose that is either too low, potentially leading to unintended pregnancy, or too high, increasing the risk of side effects.

What You Should Do

  1. Check your birth control packaging for the product names Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg) or Levonorgestrel and Ethinyl Estradiol Tablets USP (0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg).
  2. Verify the Lot numbers and expiration dates on the side of the carton or wallet: for Bekyree, look for Lot L800915 (Exp July 2020); for Levonorgestrel and Ethinyl Estradiol, look for Lot L800951 (Exp July 2020).
  3. Check the NDC numbers on your packaging: Bekyree (NDC 68180-879-11 or 68180-879-13) and Levonorgestrel and Ethinyl Estradiol (NDC 68180-857-11 or 68180-857-13).
  4. Immediately contact your healthcare provider or pharmacist for guidance on using an alternative form of contraception and to obtain a replacement prescription.
  5. Return any unused tablets from the affected lots to your pharmacy for a refund and contact Lupin Pharmaceuticals Inc. at their Baltimore office if you have additional questions regarding the return process.
  6. For further information or to report 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

Product return and refund through healthcare channels.

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

Affected Products

Product: Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg)
Model:
NDC 68180-879-11
NDC 68180-879-13
D-1055-2020
Lot Numbers:
L800915 (Exp July 2020)
Date Ranges: July 2020
Product: Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg
Model:
NDC 68180-857-11
NDC 68180-857-13
D-1056-2020
Lot Numbers:
L800951 (Exp July 2020)
Date Ranges: July 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85169
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 2 products (1,712 cartons; 9,897 cartons)
Distributed To: Nationwide
Agency Last Updated: March 24, 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.