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Lower risk Drug recall · FDA · Published February 3, 2026

Annora Pharma Pitavastatin Tablets 2mg Recall: Foreign Tablets Found

Annora Pharma recalls 2mg Pitavastatin tablets due to foreign tablets found in some bottles. This is a prescription-only product with a specific lot number and expiration date.

🇺🇸 FDA recall #D-0391-2026DrugAnnora Pharma ›
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Contact the company

Recalling firmAnnora Pharma Private LimitedSy. No.261, Plot No. 13 And 14, Annaram Village, Gummadidal Mandal, Jinnaram Mandal, Sangareddy District, Medak · Hyderabad, India
✎ GovInfoNow plain-language explainer

Annora Pharma is recalling 2mg Pitavastatin tablets because some bottles contain foreign 1mg tablets. This could lead to incorrect dosing if taken without knowing the actual contents. Read more at govinfonow.com/recall/31493-annora-pharma-pitavastatin-tablets-2mg-recall-foreign-tablets-found.

Source Summary by GovInfoNow · govinfonow.com/recall/31493-annora-pharma-pitavastatin-tablets-2mg-recall-foreign-tablets-found · Updated August 17, 2026 · FDA enforcement record: FDA #D-0391-2026

Cite this page

“Annora Pharma Pitavastatin Tablets 2mg Recall: Foreign Tablets Found.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31493-annora-pharma-pitavastatin-tablets-2mg-recall-foreign-tablets-found. Based on FDA recall #D-0391-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0391-2026%22&limit=1).

The FDA announced on Feb. 3, 2026, that Annora Pharma Private Limited is recalling Pitavastatin Tablets, 2 mg, due to the presence of foreign tablets. The hazard involves one Pitavastatin 1mg tablet found in a bottle of 2mg tablets.

How to tell if you have it

  • Brand: Annora Pharma
  • Product: Pitavastatin Tablets, 2 mg
  • Packaging: 90-count bottles
  • NDC: 72603-479-01
  • Lot #: A252487
  • Expiration: 05/31/2027
  • Quantity: 770 bottles
  • Distribution: Tennessee

The hazard

The recall addresses the presence of foreign tablets, specifically one Pitavastatin 1mg tablet found in a bottle of Pitavastatin 2mg tablets. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Annora Pharma Private Limited has one other recall on record since June 4, 2026. Other recent recalls of similar products include Granules Pharmaceuticals Trazodone 50mg Recall (Jan. 26, 2026), Bionpharma Divalproex Tablets Recall (June 26, 2026), and Golden State Baclofen Tablets Recall (Nov. 26, 2025).

How to tell if you have this one

Check for the lot number A252487 on the bottle. The product was manufactured for Northstar Rx LLC in Memphis, TN and expires May 31, 2027.

  • Brand
    Annora Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number A252487 on the bottle to confirm if it's recalled.

Where it went and when

Where it was distributed

Distributed in Tennessee.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “TN” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Tennessee.

Recall timeline

FDA published this recall 50 days after the firm started it.

1. Firm started the recall: Feb 3, 202612. FDA classified it Class III: Mar 16, 202623. Published in FDA’s Enforcement Report: Mar 25, 202632026
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall is due to foreign tablets found in some bottles, but the product is safe if the lot number is checked and the correct product is used.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0391-2026 (February 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0391-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA