Class III U.S. Food and Drug Administration

Annora Pharma Private Limited Pitavastatin Tablets, 2 mg, packaged in 90-count bottles recall: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found

Recall published 7 months ago

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

The hazard: Drug safety concern

The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

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

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0391-2026
Published
March 25, 2026
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Annora Pharma Private Limited
Product type
Prescription & OTC drugs
Units affected
770 bottles
Distribution
Tennessee
Made in
India
Lot / code info
Lot #: A252487, Exp 05/31/2027

Products covered by this recall

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.

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • A252487
  • Exp 05
  • 31
  • 2027 — 770 bottles

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 05
  • 31
  • 2027 — 770 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 72603-479-01

Package size

Match the net weight or the piece count on the front of the pack.

  • 2 mg
  • 90 count

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Annora Pharma Private Limited — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

  1. Check the lot number on your pack against the codes listed above.
  2. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  3. Keep the carton; the lot number is often printed only on the outer pack.
  4. Report side effects you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Annora Pharma Private Limited — Sy. No.261, Plot No. 13 And 14, Annaram Village, Gummadidal Mandal, Hyderabad

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Annora Pharma Private Limited prescription & otc drugs recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code A252487, Exp 05, 31; best-by date 05 or 31. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Which states were affected?

The notice lists Tennessee.

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