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Class III · Lower riskActive recall

Pitavastatin Calcium

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: A252487, Exp 05/31/2027
Where it was soldTN
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAnnora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India foreign manufacturer
Brand namePITAVASTATIN CALCIUM
Generic namePITAVASTATIN CALCIUM
Active ingredient(s)PITAVASTATIN CALCIUM
Distributed by / forNorthstar Rx LLC, Memphis, TN 38141
NDC72603-479-01
Show the full FDA record
Full product labelPitavastatin 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 firmAnnora Pharma Private Limited
DistributionTN
Quantity770 bottles
Recall initiated2026-02-03
Report date2026-03-25
Recall completed
Recall numberD-0391-2026
ClassificationClass III
FDA statusOngoing
Origin on fileHyderabad N/A India

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.