CLASS III Drug recall · Reported 23 Jun 2021 · FDA Enforcement Report

Phytonadione Tablets 5 mg recalled by AVKARE

Avkare is recalling Phytonadione Tablets 5 mg, distributed in California. The recall was initiated on 9 Jun 2021 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot: 38617 Exp. 10/2022

Quantity recalled10 cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0631-2021
FDA event ID: 88091
Recalling firm: Avkare, Pulaski, TN
Classification: Class III
Status: Terminated
Recall initiated: 9 Jun 2021
FDA classified: 16 Jun 2021
Reported: 23 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

9 Jun 2021	Recall initiated by company
16 Jun 2021	Classified by FDA	+7 days
23 Jun 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13

Where it was distributed

Distributed in Los Angeles California

California

Questions about this recall

Why was it recalled?

Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.

Which lots are affected?

Lot: 38617 Exp. 10/2022

Where was it sold?

Distributed in Los Angeles California

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Avkare

All 62

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Other Phytonadione recalls

All 8

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS II	Phytonadione Injectable Emulsion, USP 10mg/mL recalled by CiplaPhytonadione	Cipla	Potency & Assay	Nationwide
12 Oct 2022Drug	CLASS III	Phytonadione Injectable Emulsion USP, 10 mg/mL recalledPhytonadione	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
30 Jun 2021Drug	CLASS III	Phytonadione Tablets, 5 mg ablets recalled by Bausch Health Companies	Bausch Health Companies	Potency & Assay	Nationwide
3 Feb 2021Drug	CLASS III	Phytonadione Tablets 5mg recalled by Bausch Health Companies	Bausch Health Companies	Potency & Assay	Nationwide
8 Apr 2020Drug	CLASS I	Phytonadione Injectable Emulsion, USP, 10 mg/mL ampule recalledPhytonadione	Dr. Reddy's Laboratories	Packaging Defects	Nationwide