Drug FDA Class III Ongoing Foreign material

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.

Annora Pharma Private Limited Published Mar 25, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 30/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Annora Pharma Private Limited or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg

Hazards

Pitavastatin 1 mg tablet (wrong strength) · primary

Affected products (1)

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.

PITAVASTATIN CALCIUM · 770 bottles

NDC: 72603-479, 72603-480, 72603-479-01, 72603-480-01

Code info: Lot #: A252487, Exp 05/31/2027

Affected areas

Tennessee

Timeline

Initiated

Feb 3, 2026
Published

Mar 25, 2026

Recall number: D-0391-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.