FDA Drugs recall ·
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only… recall
- Recall number
- D-0391-2026
- Date
- (initiated February 3, 2026)
- Company / brand
- Annora Pharma Private Limited
Sy. No.261, Plot No. 13 And 14, Annaram Village, Gummadidal Mandal, Hyderabad, N/A, India - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 770 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: A252487, Exp 05/31/2027
Distribution
TN
States: Tennessee
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0391-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.