Rosuvastatin Tablets recall
FDA recall D-0292-2026 · initiated Dec 31, 2025
AvKARE recalled Rosuvastatin Tablets in Dec 2025 — an FDA Class II recall (D-0292-2026) because Out of specification for dissolution.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Out of specification for 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: 7,991 5x10 cartons
Details
- Product
- Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
- Recalling company
- AvKARE
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Dec 31, 2025
- FDA report date
- Jan 14, 2026
Frequently asked
- Was Rosuvastatin Tablets recalled?
- AvKARE recalled Rosuvastatin Tablets in Dec 2025 — an FDA Class II recall (D-0292-2026) because Out of specification for dissolution. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Rosuvastatin Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0292-2026 was: Out of specification for dissolution.
- Is a recalled Rosuvastatin Tablets 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 Rosuvastatin Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #49124, Exp Date 12/31/2026. 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-0292-2026.