Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported May 29, 2019
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.
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Novartis Pharmaceuticals Corp. recalled Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharma… - a critical-severity action.
Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharma… was recalled by Novartis Pharmaceuticals Corp. in May 29, 2019. Reason: Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with p…. Check the official notice for the remedy. Verify recall #D-1309-2019 with the FDA Drug before acting.
The recall
Novartis Pharmaceuticals Corp. issued this critical-severity FDA Drug recall-Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with p….
- Critical
- severity level
- Class I
- classification
- May 29, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1309-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1309-2019) was formally reported on May 29, 2019, with the manufacturer initiating the action on May 11, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Novartis Pharmaceuticals Corp. is listed as the recalling firm, operating out of East Hanover, NJ. Federal records list the affected scope as 792 cartons.
The documented reason for this recall is: Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour. Distribution data in the federal record shows the product reached: Nationwide with in the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
792 cartons
Related Recalls
6
5 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-1309-2019 |
| Date reported | May 29, 2019 |
| Date initiated | May 11, 2019 |
| Recalling firm | Novartis Pharmaceuticals Corp. |
| Firm location | East Hanover, NJ |
| Affected scope | 792 cartons |
| Distribution | Nationwide with in the United States |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1309-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Novartis Pharmaceuticals Corp.. Units affected: 792 cartons.
Why was this product recalled? ▼
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 29, 2019. Severity: Critical. Recall number: D-1309-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide with in the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1309-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported May 29, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.