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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

MALLINCKRODT PHARMACEUTICALS: Amitiza Capsules Recalled for Dosage Labeling Mix-Up

Agency Publication Date: May 23, 2019
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Summary

Mallinckrodt Pharmaceuticals is recalling approximately 170,448 bottles of Amitiza (lubiprostone) capsules, used to treat chronic constipation, because some bottles contain the wrong dosage. Bottles labeled as 8 mcg were found to contain 24 mcg capsules, and bottles labeled as 24 mcg were found to contain 8 mcg capsules. This labeling mix-up occurred across 60-count trade bottles distributed nationwide. Because patients may inadvertently take three times the intended dose or receive an ineffective lower dose, consumers should immediately verify their medication and contact a healthcare provider.

Risk

Taking the wrong dosage of medication due to a labeling error can lead to either an overdose of the active ingredient, potentially causing increased side effects, or an underdose, which may fail to treat the underlying medical condition effectively.

What You Should Do

  1. Check your prescription bottle for Amitiza (lubiprostone) capsules. Identify the dosage and lot number on the label to see if your bottle is affected.
  2. For the 8 mcg dosage (NDC 64764-080-60), check for Lot #: 3229691-61 with an expiration date of 01/2022.
  3. For the 24 mcg dosage (NDC 64764-240-60), check for Lot #: 3200626-61 with an expiration date of 02/2022.
  4. If your bottle matches these lot numbers, contact your healthcare provider or pharmacist immediately to discuss your treatment and ensure you are taking the correct dosage.
  5. Return any unused product from the affected lots to your pharmacy for a refund and contact Mallinckrodt Pharmaceuticals for further instructions.
  6. 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: Amitiza (lubiprostone) capsules, 8 mcg (60-count bottle)
Model:
NDC 64764-080-60
Recall #: D-1294-2019
Lot Numbers:
3229691-61 (Exp 01/2022)
Date Ranges: Expiration 01/2022
Product: Amitiza (lubiprostone) capsules, 24 mcg (60-count bottle)
Model:
NDC 64764-240-60
Recall #: D-1295-2019
Lot Numbers:
3200626-61 (Exp 02/2022)
Date Ranges: Expiration 02/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82830
Status: Resolved
Manufacturer: MALLINCKRODT PHARMACEUTICALS
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (89,808 bottles; 80,640 bottles)
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.