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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:

  1. Check the FDA or company notice for instructions specific to this product.
  2. 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.

  1. Pitavastatin Tablets, 2 mg, packaged in 90-count bottles

    NDC
    • 72603-479-01
    Lot code
    • A252487

Recall details

Company began the recall
Company
Annora Pharma Private LimitedHyderabad, India
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.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

  5. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)