AVKARE recalls 5mg Phytonadione tablets due to impurity levels exceeding specifications. This may affect safety for patients using prescription vitamin K.
“AVKARE Phytonadione Tablets 5mg Recall: Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36118-avkare-phytonadione-tablets-5mg-recall-impurity-risk. Based on FDA recall #D-0631-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0631-2021%22&limit=1).
AvKARE Inc. voluntarily recalled Phytonadione Tablets 5 mg due to failed impurity specifications, the FDA said on June 9, 2021. The Class III recall involved 10 cartons distributed in Los Angeles, California.
The tablets were out of specification when measuring the impurity degradant D level. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show AvKare has issued 21 other recalls since February 27, 2015. Recent brand actions include a July 20, 2022 lamotrigine recall for label errors and a December 7, 2020 trazodone recall involving a product mix-up with sildenafil. Other recent recalls of similar products include an August 25, 2026 Ajanta Pharma fluphenazine recall for impurity risk, a December 31, 2025 AvKARE rosuvastatin recall for dissolution issues, and a June 1, 2026 Sun Pharmaceutical fexofenadine recall for impurities risk.
How to tell if you have this one
Check for the product name 'Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose'. Look for the lot number 38617 and expiration date 10/2022 on the packaging.
Brand
AVKARE
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the packaging to confirm if your tablets are affected.
Where it went and when
Where it was distributed
Distributed in California.
Listed by the agency
Not listed
FDA distribution: “Distributed in Los Angeles California” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0631-2021 (June 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0631-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.