Novartis recalls Promacta 12.5 mg oral suspension (Rx only) due to possible cross-contamination with peanut flour. Affected lots manufactured by Halo Pharmaceuticals in New Jersey.
“Novartis Promacta 12.5 mg Oral Suspension Recall: Possible Peanut Flour Contamination.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38823-novartis-promacta-12-5-mg-oral-suspension-recall-possible-peanut. Based on FDA recall #D-1309-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1309-2019%22&limit=1).
Novartis Pharmaceuticals Corp. recalled Promacta (eltrombopag) 12.5 mg for Oral Suspension due to possible cross-contamination with peanut flour, the FDA said on May 11, 2019.
How to tell if you have it
Brand: Novartis
Product: Promacta (eltrombopag) 12.5 mg for Oral Suspension
Manufacturer: Halo Pharmaceuticals, Inc.
Distributor: Novartis Pharmaceuticals Corporation
NDC: 0078-0972-61
Lot codes: 8H57901589 (Exp. 09/2020), 9H57900189, 9H57900289 (Exp. 12/2020)
Quantity: 792 cartons
Distribution: Nationwide in the United States
The hazard
The product is being recalled due to possible cross-contamination with peanut flour.
Context
GovInfoNow's records show Novartis Pharmaceuticals Corp. has 8 other recalls on record since August 8, 2013. Other recent recalls of similar products include Sandimmune Oral Solution (September 8, 2023), Isopto Carpine (March 22, 2017), and Sandoz Dexmethylphenidate 10mg (July 28, 2015). Other recent recalls of similar products include Amerisource Health Primidone Tablets (May 1, 2026), Lupin prednisolone acetate ophthalmic suspension (June 4, 2026), and Amneal Primidone Tablets (June 3, 2026).
How to tell if you have this one
Check the product label for 'Promacta 12.5 mg for Oral Suspension, Rx Only'. Look for lot numbers 8H57901589 (expiring 09/2020) or 9H57900189/9H57900289 (expiring 12/2020).
Brand
Novartis
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for lot numbers 8H57901589 (expiring 09/2020) or 9H57900189/9H57900289 (expiring 12/2020) on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide with in the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1309-2019 (May 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1309-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.