CLASS II Drug recall · Reported 2 Nov 2016 · FDA Enforcement Report
Persantine (dipyridamole USP) tablets, 75 mg recalled
Boehringer Ingelheim Pharmaceuticals is recalling Persantine (dipyridamole USP) tablets, 75 mg, distributed nationwide in the US. The recall was initiated on 6 Oct 2016 and the FDA has classified it as Class II.
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-0113-2017
- FDA event ID
- 75374
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2016
- FDA classified
- 24 Oct 2016
- Reported
- 2 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 6 Oct 2016 | Recall initiated by company | |
| 24 Oct 2016 | Classified by FDA | +18 days |
| 2 Nov 2016 | Published in enforcement report | +9 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 foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Product as listed by the FDA
Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Which lots are affected?
Lot #:456520, Exp. 5/17
Where was it sold?
Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
1 other product · FDA event 75374| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dipyridamole Tablets USP, 75 mg recalled by Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals | Other | Nationwide |