FDA recall D-0391-2026

Annora Pharma Private Limited · Class III · drug

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.

Reason for recall

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

Distribution

TN

Key facts

Status
Ongoing
Initiation date
2026-02-03
Report date
2026-03-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hyderabad, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2026