Why it was recalled
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Product description
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.
Lot numbers, UPCs & expiration codes
Lot #: A252487, Exp 05/31/2027
Where it was sold
TN
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-0391-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Feb 3, 2026
- FDA report date
- Mar 25, 2026
- Quantity
- 770 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Annora Pharma Private Limited
Original FDA data
Every field from FDA enforcement report D-0391-2026, exactly as published.
Show all FDA fields
- City
- Hyderabad
- Status
- Ongoing
- Country
- India
- Event ID
- 98543
- Address
- Sy. No.261, Plot No. 13 And 14, Annaram Village, Gummadidal Mandal
- Address (line 2)
- Jinnaram Mandal, Sangareddy District, Medak
- Code information
- Lot #: A252487, Exp 05/31/2027
- Report date
- Mar 25, 2026
- Product type
- Drugs
- Recall number
- D-0391-2026
- Classification
- Class III
- Recalling firm
- Annora Pharma Private Limited
- Product quantity
- 770 bottles
- Reason for recall
- Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.
- Distribution pattern
- TN
- Recall initiation date
- Feb 3, 2026
- Initial firm notification
- Letter
- Center classification date
- Mar 16, 2026