FDA Recall D-0391-2026

Annora Pharma Private Limited · Hyderabad, N/A

Class III Ongoing 100 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

Lot / code: Lot #: A252487, Exp 05/31/2027

Quantity: 770 bottles

Reason for recall

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

Recall record

Recall number: D-0391-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: TN
Recall initiated: 2026-02-03
Classified by FDA Center: 2026-03-16
FDA published: 2026-03-25
Recalling firm: Annora Pharma Private Limited
Firm location: Hyderabad, N/A, India

Drug identification

Brand name(s): PITAVASTATIN CALCIUM
Generic name(s): PITAVASTATIN CALCIUM
Manufacturer(s): NorthStar RxLLC
NDC(s): 72603-479, 72603-480
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls