The Recall Desk
ModerateFDA (Drugs)·D-0488-2021·Announced 2021-06-02

Cardinal Health Recalls FaBB Vitamin B6 Supplement Due to Temperature Excursions

Cardinal Health is recalling 54 bottles of FaBB Vitamin B6, Folic Acid, and Vitamin B12 dietary supplements due to intermittent temperature excursions during storage.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a CGMP deviation (temperature excursion) which is a quality control issue rather than a confirmed high-risk pathogen or structural defect, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Cardinal Health Inc. is recalling 54 bottles of FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg, Folic Acid 2.2 mg, and Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement, 100 Tablets. The product is distributed by H2-Pharma, LLC. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product was distributed in Florida, Georgia, and South Carolina. All lots were distributed between February 23, 2021, and March 10, 2021. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have purchased this product should check their inventory for the specific product name and distribution dates. If the product is found, consumers should stop using it and contact the distributor or manufacturer for instructions on return or disposal.

The recalled product

Product
FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement 100 Tablets Distributed by: H2-Pharma, LLC 2010 Berry Chase Place Montgomery, AL 36117
Manufacturer
Cardinal Health Inc.
Category
Drug — Dietary Supplement
Hazard
Affected units
54

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots distributed 02/23/2021 through 03/10/2021.

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

See all →

Same hazard · temperature excursion

See all →