Class III · Low risk
Pitavastatin Tablets
Failed Impurity/Degradation Specifications
Pitavastatin Tablets (Pitavastatin Calcium)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was 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.
Affected NDC
72603-0479-01
Compare with the code on your package — it is the most precise check available.
Drug: Pitavastatin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| pitavastatin calcium NDC 72603-0479 |
2.09 mg/1 | Tablet, Film Coated Oral |
NorthStar RxLLC | Rx |
- Recalling firm
- Annora Pharma Private Limited
- NDC code
- 72603-479-01
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0391-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Pitavastatin recalls
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Class III · Low risk
Pitavastatin Tablets
Failed Impurity/Degradation Specifications
Class III · Low risk
Pitavastatin Tablets
Failed Impurities/Degradation Specifications.
Class III · Low risk
Pitavastatin Tablets
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Livalo (pitavastatin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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All 2026 recalls
Class II · Moderate risk
Lacosamide Tablets
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
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