Why it was recalled
Failed Impurity/Degradation Specifications
Product description
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Lot numbers, UPCs & expiration codes
Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0529-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 26, 2025
- FDA report date
- Jul 9, 2025
- Quantity
- 8,573 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0529-2025, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 97160
- Address
- 615 N 1st St
- Code information
- Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
- Postal code
- 38478-2403
- Report date
- Jul 9, 2025
- Product type
- Drugs
- Recall number
- D-0529-2025
- Classification
- Class III
- Recalling firm
- AvKARE
- Product quantity
- 8,573 bottles
- Reason for recall
- Failed Impurity/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 26, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 16, 2025