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Moderate recall: A hazard has been identified, with no injuries reported yet. Follow the steps below.

AvKARE 2025-07-09 Health moderate FDA
Health · FDA · Recall #FDA-D-0528-2025

Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE,… Recall

Issued July 9, 2025 · AvKARE

In July 2025, AvKARE recalled the Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE,…, a moderate health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Failed Impurity/Degradation Specifications

What you should do

  1. 1 Stop using Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE,… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact AvKARE to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
AvKARE
Category
Health
Recall date
July 9, 2025
Units affected
Not reported
Sold at
Nationwide in the USA
Recall number
FDA-D-0528-2025
Made in
United States
Issuing agency
FDA

In context

  • AvKARE has 10 recalls in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 691st Health recall we've logged in 2025.
Read the official FDA notice

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