Pitavastatin tablets recalled after failing impurity and degradation specifications
Pitavastatin Tablets 1 mg from AvKARE are being recalled because they failed impurity and degradation specifications. 1,560 bottles are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall for an out-of-specification impurity result with no named impurity, measured level or health consequence stated.
Plain-English summary
Pitavastatin Tablets, 1 mg, 90 tablets per bottle, prescription only, manufactured for AvKARE of Pulaski, Tennessee, NDC 42291-905-90, are being recalled. The action covers 1,560 bottles.
The stated reason is that the product failed impurity and degradation specifications. The FDA classified the action as Class III, its least serious classification. The source does not name the impurity or state a measured level.
Affected lots include 46208 expiring 10/31/2025, 47738 expiring 09/30/2026 and 46943 expiring 05/31/2026, together with the further lots listed in the recall notice. Distribution was nationwide in the USA.
Patients holding affected lots should speak to their pharmacist before stopping treatment, and pharmacies should follow the instructions issued by AvKARE.
The recalled product
- Product
- PITAVASTATIN (PITAVASTATIN CALCIUM)
- Brand
- PITAVASTATIN
- Manufacturer
- AvKARE
- Category
- Drug — Oral tablet
- Hazard
- impurity-specification
- degradation
- out-of-specification
- class-iii
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 (7)
- Lot
- expiry: Lot 46208
- exp 10/31/2025
- Lot 47738
- exp 09/30/2026
- Lot 46943
- exp 05/31/2026
Distribution
Distributed nationwide across the United States.
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