February 2026 FDA Recall Pitavastatin Calcium by Annora Pharma Private Limited
D-0391-2026 - Presence of foreign tablets/capsules
This Class III drug recall was voluntarily initiated by Annora Pharma Private Limited on February 3, 2026 for the product Pitavastatin Calcium. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in TN and the recall is currently ongoing.
Recall Number: D-0391-2026
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
02-03-2026
03-25-2026
770 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Annora Pharma Private Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TN
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# : A252487, Exp 05/31/2027
