Promacta Oral Suspension (Novartis) – Peanut Contamination (2019)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61.
Brand
Novartis Pharmaceuticals Corp.
Lot Codes / Batch Numbers
Lot #: 8H57901589, Exp. 09/2020, 9H57900189 and 9H57900289, Exp. 12/2020.
Products Sold
Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020.
Novartis Pharmaceuticals Corp. is recalling Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, due to Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026