AvKARE Pitavastatin Tablets Recall: Failed Impurity/Degradation Risk
AvKARE recalls 1 mg Pitavastatin tablets (Rx only) due to failed impurity and degradation specifications. Affected lots expire 10/31/2025 and 09/30/2026. Consumers should contact for details.
Recall notice
Failed Impurity/Degradation Specifications
Contact the company
What happened, in plain English
AvKARE is recalling 1 mg Pitavastatin tablets (90 tablets per bottle) that may have failed impurity or degradation specifications. This could pose a risk to users taking the medication as prescribed. Read more at govinfonow.com/recall/32011-avkare-pitavastatin-tablets-recall-failed-impurity-degradation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32011-avkare-pitavastatin-tablets-recall-failed-impurity-degradation-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0528-2025
Cite this page
“AvKARE Pitavastatin Tablets Recall: Failed Impurity/Degradation Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32011-avkare-pitavastatin-tablets-recall-failed-impurity-degradation-risk. Based on FDA recall #D-0528-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0528-2025%22&limit=1).
Why it’s dangerous
The tablets may have failed impurity or degradation specifications, which could affect the medication's safety and effectiveness. This means the tablets might not work as intended or could cause harm to users.
Who’s affected
People with a prescription for AvKARE Pitavastatin tablets (1 mg, 90 tablets per bottle) manufactured in Pulaski, TN. Those who have the specific lots listed in the recall are most at risk.
How to tell if you have this one
Check your bottle for the brand 'AvKARE', product name 'Pitavastatin Tablets', 1 mg strength, 90 tablets per bottle, and prescription label. The specific lots are 46208 (expires 10/31/2025), 47738 (expires 09/30/2026), or 46943 (expires 05/31/2026).
- Brand
AvKARE- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Ongoing- Distribution
Nationwide in the USA- NDC
42291-906-90, 42291-907-90, 42291-905-90
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0528-2025 | Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90; Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026; | 1,560 bottles |
| D-0529-2025 | Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90; Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026 | 8,573 bottles |
What to do — step by step
Check Your Medication
Verify the lot number and expiration date on your bottle to see if it matches the recalled lots: 46208 (exp 10/31/2025), 47738 (exp 09/30/2026), or 46943 (exp 05/31/2026).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 13 days after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class III
Dates from the agency record only; steps without a date are left out.
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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-0528-2025 (June 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0528-2025 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.