Persantine 75mg Tablets Recall: Foreign 50mg Tablets Found
Boehringer Ingelheim recalls 75mg Persantine tablets where 50mg tablets were mistakenly included. This could cause incorrect dosing if taken.
Lower-risk 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.
Contact the company
What happened, in plain English
Boehringer Ingelheim is recalling 75mg Persantine tablets that contain 50mg tablets by mistake. This could lead to incorrect dosing if someone takes the product as directed. Read more at govinfonow.com/recall/42297-persantine-75mg-tablets-recall-foreign-50mg-tablets-found.
Source Summary by GovInfoNow · govinfonow.com/recall/42297-persantine-75mg-tablets-recall-foreign-50mg-tablets-found · Updated October 9, 2026 · FDA enforcement record: FDA #D-0113-2017
Cite this page
“Persantine 75mg Tablets Recall: Foreign 50mg Tablets Found.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42297-persantine-75mg-tablets-recall-foreign-50mg-tablets-found. Based on FDA recall #D-0113-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0113-2017%22&limit=1).
Why it’s dangerous
The 75mg Persantine bottles contain 50mg tablets by mistake. This could cause incorrect dosing if taken as a 75mg tablet when it's actually a 50mg tablet. The risk is low because the product is prescription-only and the mistake is in the tablet count, not the active ingredient.
Who’s affected
Prescription patients who have the 75mg Persantine tablets with NDC 0597-0019-01 and Lot #456520. Patients taking Persantine for heart conditions are most at risk.
How to tell if you have this one
Check for 75mg Persantine tablets with NDC 0597-0019-01 and Lot #456520. The product is prescription-only and sold by Boehringer Ingelheim.
- Brand
Boehringer Ingelheim- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0113-2017 | 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; Lot #:456520, Exp. 5/17 | 2562 bottles |
| D-0114-2017 | DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25; Lot #: 554820, Exp 5/17 | 6400 bottles |
What to do — step by step
Check Product Label
Look for NDC 0597-0019-01 and Lot #456520 on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The product is safe to use if you verify the label and confirm it's the correct strength before taking.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0113-2017 (October 6, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0113-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.