Recall Ledger

Pitavastatin Tablets recall (Annora Pharma Private Limited)

DrugClass IIIOngoing

Summary: Annora Pharma Private Limited is recalling 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: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg.

What is being recalled

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

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

How serious is it

Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.

Where it was sold

TN (states named: Tennessee)

How to tell if yours is affected

Lot #: A252487, Exp 05/31/2027

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0391-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass III
StatusOngoing
Recall startedFebruary 3, 2026
ReportedMarch 25, 2026
CompanyAnnora Pharma Private Limited
Company locationHyderabad, N/A, India
Initiated byVoluntary: Firm initiated
Quantity770 bottles

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