FDA-Drug2026-03-25Class IIIPROCESSING DEFECT
Annora Pharma Pitavastatin 2mg tablets recalled for wrong-strength tablet contamination
What this means
A 1 mg Pitavastatin tablet was found mixed into a bottle labeled as containing 2 mg tablets. This occurred in one lot (A252487) distributed in Tennessee. Taking the wrong dose by mistake could affect how well your cholesterol medication works.
- Check if you have Pitavastatin 2 mg, lot A252487, expiration 05/31/2027 (NDC 72603-479-01)
- Do not take tablets from the affected bottle
- Call your pharmacist or doctor before stopping your medication
- Return the bottle to your pharmacy
The agency's original wording
Hazard
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Intended for
Adults
Illnesses reported
None reported
Sold states
TN
Affected count
770 bottles
Manufactured in
Sy. No.261, Plot No. 13 And 14, Annaram Village, Gummadidal Mandal, Jinnaram Mandal, Sangareddy District, Medak, Hyderabad, N/A, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2026More Annora Pharma recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.