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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Novartis Pharmaceuticals Corp.: Promacta (eltrombopag) Oral Suspension Recalled for Possible Peanut Contamination

Agency Publication Date: May 22, 2019
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Summary

Novartis Pharmaceuticals Corp. is recalling 792 cartons of Promacta (eltrombopag) 12.5 mg for Oral Suspension. This prescription drug is being recalled because it may have been cross-contaminated with peanut flour during the manufacturing process. Consumers who are allergic to peanuts should not use this medication as it could cause a severe allergic reaction.

Risk

The product may contain trace amounts of peanut flour due to cross-contamination at the manufacturing facility. Individuals with a peanut allergy who consume this product could experience life-threatening anaphylaxis or other serious allergic reactions.

What You Should Do

  1. Check your medication packaging for Promacta (eltrombopag) 12.5 mg for Oral Suspension with NDC 0078-0972-61.
  2. Verify if your product matches one of the affected lot numbers: 8H57901589 (Exp. 09/2020), 9H57900189 (Exp. 12/2020), or 9H57900289 (Exp. 12/2020).
  3. If you have an affected lot, contact your healthcare provider or pharmacist immediately for guidance on how to obtain a safe replacement and to discuss any health concerns.
  4. Return any unused portion of the recalled medication to your pharmacy to receive a refund.
  5. Contact Novartis Pharmaceuticals Corp. at 1-888-669-6682 or visit their website for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Drug recall remedy

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

Affected Products

Product: Promacta (eltrombopag) 12.5 mg for Oral Suspension
Model:
NDC 0078-0972-61
Recall #: D-1309-2019
Lot Numbers:
8H57901589 (Exp. 09/2020)
9H57900189 (Exp. 12/2020)
9H57900289 (Exp. 12/2020)
Date Ranges: Expiration 09/2020, Expiration 12/2020

Product Images

“Photo of Promacta 12.5mg oral suspension”

“Photo of Promacta 12.5mg oral suspension”

“Alternate Photo of Promacta 12.5mg oral suspension”

“Alternate Photo of Promacta 12.5mg oral suspension”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82820
Status: Resolved
Manufacturer: Novartis Pharmaceuticals Corp.
Sold By: Pharmacies
Manufactured In: Ireland, United States
Units Affected: 792 cartons
Distributed To: Nationwide
Agency Last Updated: May 29, 2019

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 · FDA Press Release · 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.