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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

Lupin Pharmaceuticals Inc.: My Way Emergency Contraceptive Recalled for Unapproved Packaging Configuration

Agency Publication Date: May 22, 2018
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Summary

Lupin Pharmaceuticals Inc. is recalling approximately 87,562 units of My Way (levonorgestrel) 1.5 mg emergency contraceptive tablets. The recall was initiated because the specific two-pack carton configuration was released to the market without the required regulatory approval from the FDA. This voluntary action involves products distributed nationwide across the United States in various lot numbers with expiration dates in 2018 and 2019.

Risk

The product itself meets quality standards, but the two-pack packaging setup did not receive the necessary FDA approval before being sold. Using a drug product in a configuration not approved by regulatory agencies can lead to inconsistencies in patient labeling or instructions for use.

What You Should Do

  1. Check your medication packaging to see if you have My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, which contains two treatments per carton.
  2. Verify the UPC and Lot numbers on the carton: look for UPC 3 43386-622-31 3 with lot numbers M16317A1, M16317A4, or M16317A5 (Exp 11/18).
  3. Also check for UPC 3 68180 85212 4 with lot numbers L700329 (Exp 08/19) or L700670 (Exp 11/19).
  4. Contact your healthcare provider or pharmacist for guidance regarding the use of this specific two-pack product.
  5. Return any unused two-pack cartons to the pharmacy or place of purchase for a refund.
  6. Contact Lupin Pharmaceuticals Inc. at their Baltimore, Maryland headquarters if you have further questions regarding the return process.
  7. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider or return to pharmacy.

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

Affected Products

Product: My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each (2 Treatments per carton)
Model:
D-0837-2018
UPC Codes:
343386622313
Lot Numbers:
M16317A1 (Exp 11/18)
M16317A4 (Exp 11/18)
M16317A5 (Exp 11/18)
Date Ranges: Expiration 11/18
Product: My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each (2 Treatments per carton)
Model:
D-0838-2018
UPC Codes:
368180852124
Lot Numbers:
L700329 (Exp 08/19)
L700670 (Exp 11/19)
Date Ranges: Expiration 08/19, Expiration 11/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80097
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies nationwide
Manufactured In: United States, India
Units Affected: 2 products (43,922 cartons; 43,640 cartons)
Distributed To: Nationwide

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.