Pitavastatin Tablets recall
FDA recall D-0528-2025 · initiated Jun 26, 2025
AvKARE recalled Pitavastatin Tablets in Jun 2025 — an FDA Class III recall (D-0528-2025) because Failed Impurity/Degradation Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurity/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
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: 1,560 bottles
Details
- Product
- Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
- Recalling company
- AvKARE
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 26, 2025
- FDA report date
- Jul 9, 2025
Frequently asked
- Was Pitavastatin Tablets recalled?
- AvKARE recalled Pitavastatin Tablets in Jun 2025 — an FDA Class III recall (D-0528-2025) because Failed Impurity/Degradation Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Pitavastatin Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0528-2025 was: Failed Impurity/Degradation Specifications
- Is a recalled Pitavastatin 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. 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 Pitavastatin Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;. 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-0528-2025.