FDA recall record

Pitavastatin Tablets, 2 mg recall — FDA D-0391-2026

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

Class IIIclassification
D-0391-2026official record ID
Mar 25, 2026report date

Recall record at a glance

Official recordD-0391-2026
CategoryDrug Recalls
ClassificationClass III
FDA record statusOngoing
Recalling firmAnnora Pharma Private Limited
Report dateMar 25, 2026
Recall initiation dateFeb 3, 2026
Quantity770 bottles
LocationHyderabad, N/A, India

Official 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.

Why the product was recalled

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

Distribution information

TN

How to read the classification

FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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