CLASS II Drug recall · Reported 6 Nov 2019 · FDA Enforcement Report
Prasugrel Tablets 5 mg recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Prasugrel Tablets 5 mg, distributed nationwide in the US. The recall was initiated on 18 Oct 2019 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-0155-2020
- FDA event ID
- 84039
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Brand
- Prasugrel
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Oct 2019
- FDA classified
- 28 Oct 2019
- Reported
- 6 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 18 Oct 2019 | Recall initiated by company | |
| 28 Oct 2019 | Classified by FDA | +10 days |
| 6 Nov 2019 | 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
Failed Dissolution Specification: Low out of specification dissolution results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Dissolution Specification: Low out of specification dissolution results.
Which lots are affected?
Lot #: 3089793, Exp. Date September 2020
Where was it sold?
Nationwide within the United States
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.
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Prasugrel recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Prasugrel Tablets, 5 mg recalled by Golden State Medical SupplyPrasugrel | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Prasugrel Tablets, USP, 5 mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |