Promacta — Class I drug recall D-1309-2019
Terminated recall by Novartis Pharmaceuticals Corp., reported 2019-05-29, distributed nationwide. Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with pe
| Recall number | D-1309-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Pharmaceuticals Corp., East Hanover, NJ, United States |
| Recall initiated | 2019-05-11 |
| Classified | 2019-05-29 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2023-11-28 |
| Distributed | Nationwide (US) |
| Quantity | 792 cartons |
| NDC | 00078-0684, 00078-0684-15, 00078-0685, 00078-0685-15, 00078-0686, 00078-0686-15, 00078-0686-55, 00078-0687, 00078-0687-15, 00078-0697, 00078-0697-19, 00078-0697-23, 00078-0697-61, 00078-0972, 00078-0972-19, 00078-0972-23, 00078-0972-61 |
| Lot numbers | 8H57901589, 9H57900189, 9H57900289 |
| Expiration dates | 2020-09, 2020-12 |
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.
Reason for recall
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1309-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.