Drug FDA Class III Ongoing Failed specifications

Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

AvKARE Published Jul 9, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact AvKARE or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Failed Impurity/Degradation Specifications

Hazards

Failed Impurity/Degradation Specifications · primary

Affected products (1)

Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

PITAVASTATIN · 1,560 bottles

NDC: 42291-905, 42291-906, 42291-907, 42291-906-90, 42291-907-90, 42291-905-90

Lot codes: 46208, 47738, 46943

Code info: Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;

Affected areas

Nationwide

Timeline

Initiated

Jun 26, 2025
Published

Jul 9, 2025

Recall number: D-0528-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.