Rosuvastatin Tablets Recalled for Out-of-Specification Dissolution
AvKARE is recalling Rosuvastatin 10 mg tablets (Lot #49124) distributed nationwide because the tablets do not dissolve at the required rate, which may affect medication efficacy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II pharmaceutical quality defect affecting drug efficacy. The dissolution failure represents a risk-of-harm product situation for patients relying on statin therapy, although no illnesses or injuries have been reported.
Plain-English summary
AvKARE is recalling Rosuvastatin 10 mg tablets (Lot #49124, expiring 12/31/2026, NDC 50268-709-15) distributed nationwide due to out-of-specification dissolution. The tablets do not dissolve at the required rate, which could affect medication bioavailability and therapeutic efficacy.
The recall affects approximately 7,991 cartons of 5x10 unit-dose packaging distributed throughout the United States.
Patients taking this medication should contact their pharmacy or healthcare provider before making any changes. Do not stop taking rosuvastatin without consulting your doctor, as this could increase cardiovascular risk. Pharmacies should remove affected batches from inventory and notify customers who may have received them.
AvKARE has initiated this recall and is working with healthcare providers and pharmacies on notification and replacement options.
The recalled product
- Product
- ROSUVASTATIN (ROSUVASTATIN)
- Brand
- ROSUVASTATIN
- Manufacturer
- AvKARE
- Category
- Drug — Statin / Cardiovascular
- Hazard
- dissolution-defect
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 #49124
- Exp Date 12/31/2026
Distribution
Distributed nationwide across the United States.
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