CLASS I Drug recall · Reported 19 Jul 2017 · FDA Enforcement Report
Brilinta (ticagrelor) tablets, 90 mg Professional Sample recalled
AstraZeneca Pharmaceuticals is recalling Brilinta (ticagrelor) tablets, 90 mg Professional Sample, distributed nationwide in the US. The recall was initiated on 25 May 2017 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-0958-2017
- FDA event ID
- 77336
- Recalling firm
- AstraZeneca Pharmaceuticals, Newark, DE
- Brand
- Brilinta
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 25 May 2017
- FDA classified
- 11 Jul 2017
- Reported
- 19 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
- Drug class
- Blood Thinners
Timeline
| 25 May 2017 | Recall initiated by company | |
| 11 Jul 2017 | Classified by FDA | +47 days |
| 19 Jul 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Product as listed by the FDA
BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden, NDC 0186-0777-08.
Where it was distributed
Nationwide in the USA and Puerto Rico to physician offices.
Questions about this recall
Why was it recalled?
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Which lots are affected?
Lot # JB5047, Exp 10/19
Where was it sold?
Nationwide in the USA and Puerto Rico to physician offices.
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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Other Ticagrelor recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Brilinta ticagrelar tablets 60 mg recalled by Cardinal HealthBrilinta | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |