Pitavastatin Tablets Recalled Due to Foreign Tablet Presence

This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified April 10, 2026.

So here's something you need to know about if you're taking Pitavastatin tablets: Annora Pharma Private Limited has issued a voluntary product recall in the United States for a specific lot of their 2mg tablets. Nobody wants to find out their medication has an issue, so let's break down what's happening.

Why the Pitavastatin Tablets Recall?

Based on the official recall notice, the problem comes down to a mix-up inside one batch of bottles. Specifically, one bottle of Pitavastatin tablets, 2mg, was found to contain a stray Pitavastatin tablet, 1mg. The agency confirmed that this could potentially lead to incorrect dosage for U.S. consumers.

Annora Pharma Private Limited, the manufacturer, initiated this Class III recall after discovering the foreign tablet during routine quality control. A Class III recall means that the situation is not likely to cause adverse health consequences. But it's still important for American shoppers to check their medication.

Which Product is Affected?

Here's what you need to look for. This product recall affects Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only. It's manufactured for Northstar Rx LLC, Memphis, TN 38141, but made by Annora Pharma Pvt. Ltd., Sengareddy - 502313, Telengana, India. Look for NDC number 72603-479-01. The specific lot number to watch out for is A252487, with an expiration date of 05/31/2027. Approximately 770 bottles are affected in this product recall.

The distribution of this specific lot was limited to Tennessee. If you live in TN and are taking this medication, pay close attention. But even if you don't live in Tennessee, but purchased the medication there while traveling or through online pharmacies, you may have the affected lot. Double-check your bottle to be on the safe side. You won't find this medication at major retailers like Walmart, Target, Amazon, or Costco under the Northstar Rx label, as it is a prescription medication distributed through pharmacies.

What To Do Right Now

1. Immediately examine your bottle of Pitavastatin tablets, 2mg, and compare the lot number to A252487 to confirm whether your medication is part of this product recall.
2. If your bottle matches the recalled lot number, stop taking the medication and contact your healthcare provider right away for medical advice and to discuss alternative medication options.
3. Contact your pharmacy to arrange for a replacement of your Pitavastatin tablets, 2mg, ensuring that the new medication is from a different, unaffected lot.

What's the Potential Risk?

The primary concern stems from the potential for incorrect dosage. Someone taking a bottle of 2mg tablets which has a 1mg tablet inside could end up taking less medication than prescribed. For some people, a slightly lower dose might not have any immediate effect. But for others, especially those with more serious health conditions, it could lead to a less effective treatment. It's important to remember that this is a Class III recall, meaning the risk of serious adverse health consequences is considered low, but it’s still important to take the necessary precautions. If you experience any unusual symptoms, contact your doctor or other healthcare professional immediately.

Annora Pharma Private Limited is working to resolve the situation and prevent similar issues in the future. While this appears to be an isolated incident, it highlights the importance of quality control and vigilance in the pharmaceutical industry. This is the first recall from Annora Pharma Private Limited that the FDA has announced recently, and hopefully it will be their last.

Frequently Asked Questions

Q: What exactly is pitavastatin used for?

Pitavastatin is a prescription medicine used to lower cholesterol in people with high cholesterol, and it's often prescribed to help prevent cardiovascular disease.

Q: How can I tell if my medication is part of the Pitavastatin tablets recall?

Check the label on your bottle for the following information: Product: Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, NDC 72603-479-01, Lot #: A252487, Exp 05/31/2027.

Q: What should I do if I accidentally took a 1mg tablet from the recalled bottle?

Contact your doctor or pharmacist to discuss any potential health effects or adjust your medication schedule to ensure you are receiving the correct dosage.

Q: Will I get a refund for the recalled Pitavastatin tablets?

Contact your pharmacy where you purchased the medication or Northstar Rx LLC to inquire about their replacement or refund policy for the recalled Pitavastatin tablets.

Q: Where was this medication sold across the U.S.?

While the distribution of this specific lot was in TN, remember that medication can travel. If you got your prescription filled in Tennessee, or order from an online pharmacy that ships from there, check your lot number.

This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.