Prasugrel HCI recall
FDA recall D-0847-2026 · initiated Aug 21, 2026
Golden State Medical Supply Inc. recalled Prasugrel HCI in Aug 2026 — an FDA Class II recall (D-0847-2026) because Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6791 30-count bottles
Details
- Product
- Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.
- Recalling company
- Golden State Medical Supply Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Aug 21, 2026
- FDA report date
- Sep 9, 2026
Frequently asked
- Was Prasugrel HCI recalled?
- Golden State Medical Supply Inc. recalled Prasugrel HCI in Aug 2026 — an FDA Class II recall (D-0847-2026) because Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Prasugrel HCI recalled?
- Per the FDA enforcement record, the reason for recall D-0847-2026 was: Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
- Is a recalled Prasugrel HCI dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Prasugrel HCI are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # GS062298, Exp Date: 09/30/ 2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0847-2026.