Pitavastatin Tablets recall
FDA recall D-0391-2026 · initiated Feb 3, 2026
Annora Pharma Private Limited recalled Pitavastatin Tablets in Feb 2026 — an FDA Class III recall (D-0391-2026) because Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 770 bottles
Details
- 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.
- Recalling company
- Annora Pharma Private Limited
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- TN
- Initiated
- Feb 3, 2026
- FDA report date
- Mar 25, 2026
Frequently asked
- Was Pitavastatin Tablets recalled?
- Annora Pharma Private Limited recalled Pitavastatin Tablets in Feb 2026 — an FDA Class III recall (D-0391-2026) because Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Pitavastatin Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0391-2026 was: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
- Is a recalled Pitavastatin Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Pitavastatin Tablets are affected?
- Distributed: TN. The recall covers these lots — Lot #: A252487, Exp 05/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0391-2026.