Golden State Medical Supply Recalls Prasugrel Tablets for Failed Dissolution
Golden State Medical Supply is recalling 6,791 bottles of 10mg Prasugrel tablets because the product failed dissolution specifications.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences (such as therapeutic failure due to failed dissolution) corresponds to a severity score of 4 (Severe), as it is not a Class I recall but involves a significant quality defect.
Plain-English summary
Golden State Medical Supply Inc. is recalling 6,791 30-count bottles of Prasugrel HCI, Tablets, USP, 10mg. The product is marketed by GSMS, Incorporated, located in Camarillo, CA, and is distributed nationwide in the United States. The specific lot involved is # GS062298, with an expiration date of 09/30/2026.
The recall was initiated due to failed dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the appropriate rate in the body. When this specification is not met, the medication may not work as intended.
Patients and healthcare providers should stop using the affected lot and contact their healthcare provider for a replacement or alternative treatment. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PRASUGREL (PRASUGREL)
- Brand
- PRASUGREL
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Prescription Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # GS062298
- Exp Date: 09/30/ 2026.
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · PRASUGREL
- ModerateMylan Recalls Prasugrel Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-09
- HighFDA Recalls Prasugrel Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2025-03-26
- HighPrasugrel 5 mg Tablets Recalled Due to Failed Dissolution Specifications
FDA (Drugs) · 2025-03-26
- ModerateMylan Recalls Prasugrel Tablets Due to Dissolution Specification Failure
FDA (Drugs) · 2019-11-06
Same manufacturer · Golden State Medical Supply Inc.
See all →- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
- HighBaclofen tablet bottles recalled over the presence of foreign tablets
FDA (Drugs) · 2025-12-24
Same hazard · failed dissolution
See all →- ModerateNovartis Recalls Diovan Valsartan Tablets Due to Failed Dissolution Specifications
FDA (Drugs) · 2026-08-19
- LowSupernus Recalls Trokendi XR Capsules for Failed Dissolution Specifications
FDA (Drugs) · 2026-07-29
- HighAscend amlodipine and olmesartan tablets failed dissolution specifications
FDA (Drugs) · 2026-06-10
- HighLannett niacin extended-release tablets failed dissolution specifications during stability
FDA (Drugs) · 2026-06-10
- HighMajor Pharmaceuticals memantine extended-release capsules fail dissolution specifications
FDA (Drugs) · 2026-04-22