CLASS I Drug recall · Reported 29 May 2019 · FDA Enforcement Report
Promacta (eltrombopag) 12.5 mg for Oral Suspension recalled
Novartis Pharmaceuticals is recalling Promacta (eltrombopag) 12.5 mg for Oral Suspension, distributed nationwide in the US. The recall was initiated on 11 May 2019 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1309-2019
- FDA event ID
- 82820
- Recalling firm
- Novartis Pharmaceuticals, East Hanover, NJ
- Brand
- Promacta
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 May 2019
- FDA classified
- 29 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
Timeline
| 11 May 2019 | Recall initiated by company | |
| 29 May 2019 | Classified by FDA | +18 days |
| 29 May 2019 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Product as listed by the FDA
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.
Where it was distributed
Nationwide with in the United States
Questions about this recall
Why was it recalled?
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Which lots are affected?
Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020.
Where was it sold?
Nationwide with in the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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