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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

Cardinal Health dba Specialty Pharmaceutical Services: Nucala (mepolizumab) Injection Recalled Due to Temperature Abuse

Agency Publication Date: September 20, 2019
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Summary

Cardinal Health is recalling 38 syringes of Nucala (mepolizumab) Injection, 100 mg/mL, because the medication was stored and shipped outside of its required temperature range. This drug is a prescription medication used for subcutaneous injection. Because the medication was not kept at the correct temperature, its effectiveness and safety cannot be guaranteed. Consumers who have received these specific syringes should contact their healthcare provider or pharmacist immediately.

Risk

Storing medication outside of its labeled temperature requirements, known as temperature abuse, can cause the drug to break down or lose its potency. This means the medication may not work as intended to treat the patient's condition, or it could potentially cause an adverse reaction.

What You Should Do

  1. Identify if you have the affected medication by checking the packaging for Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe with NDC 0173-0892-42.
  2. Check the side of the box or the syringe label for Lot Number S25X and an Expiration Date of 03/31/21.
  3. If your medication matches Lot S25X, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement.
  4. Return any unused syringes from this specific lot to your pharmacy for a refund and further instructions.
  5. Contact Cardinal Health dba Specialty Pharmaceutical Services at their distribution location in La Vergne, TN for more information regarding this recall.
  6. For general questions regarding food and drug safety, 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: Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe (Single-Dose)
Model:
NDC 0173-0892-42
Recall #: D-1876-2019
Lot Numbers:
S25X (Exp. 03/31/21)
Date Ranges: Expiration Date: 03/31/21

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83731
Status: Resolved
Manufacturer: Cardinal Health dba Specialty Pharmaceutical Services
Sold By: Specialty Pharmaceutical Services
Manufactured In: United States
Units Affected: 38 syringes
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.