FDA recall, , Low risk
Northstar Rx Pitavastatin Tablets
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg.
What happened
Annora Pharma Private Limited, based in Hyderabad, India, recalled 770 bottles of Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, because one Pitavastatin tablet 1mg was found in a bottle of Pitavastatin tablets 2mg. The product is Rx only and manufactured for Northstar Rx LLC, Memphis, TN 38141. The recall began February 3, 2026, and was added to the FDA's Enforcement Report on March 16, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles
- NDC
- 72603-479-01
- Lot code
- A252487
Recall details
- Company began the recall
- Sold in
- Company
- Annora Pharma Private LimitedHyderabad, India
- Hazard
- Foreign object
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98543
- Recall number
- D-0391-2026
- Quantity recalled
- 770 bottles
All recalls from Annora Pharma Private Limited
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated

