The Recall Desk
ModerateFDA (Drugs)·D-0391-2026·Announced 2026-03-25

Pitavastatin 2 mg bottle found to contain a 1 mg tablet

Annora Pharma is recalling one lot of Pitavastatin Tablets 2 mg after one Pitavastatin 1 mg tablet was found in a bottle of 2 mg tablets.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The rubric places FDA Class III recalls at 1 or 2, and this concerns a single lower-strength tablet of the same medicine found in one bottle, with no hazard or injury stated.

Plain-English summary

Annora Pharma Private Limited is recalling Pitavastatin Tablets, 2 mg, in 90-count bottles, prescription only, made for Northstar Rx LLC of Memphis, Tennessee, NDC 72603-479-01. About 770 bottles were distributed in Tennessee. The FDA has classified this recall as Class III.

The recall was initiated for the presence of foreign tablets or capsules: one Pitavastatin 1 mg tablet was found in a bottle of Pitavastatin 2 mg tablets.

Affected product is lot A252487 with an expiry date of 05/31/2027.

Patients and pharmacies can identify affected product by the NDC and lot number above, and may contact Annora Pharma Private Limited for further information.

The recalled product

Product
PITAVASTATIN CALCIUM (PITAVASTATIN CALCIUM)
Brand
PITAVASTATIN CALCIUM
Affected units
770

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: A252487
  • Exp 05/31/2027

Distribution

Distributed in 1 state:

Same manufacturer · Annora Pharma Private Limited

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