The Recall Desk
ModerateFDA (Drugs)·D-0585-2021·Announced 2021-06-02

Cardinal Health Recalls Folivane-Plus Capsules Due to Temperature Excursions

Cardinal Health is recalling 80 bottles of Folivane-Plus capsules because they were intermittently exposed to 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 hospitalizations, injuries, or illnesses. The hazard is a CGMP deviation (temperature excursion) without reported harm, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Cardinal Health Inc. is recalling 80 bottles of Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules (90 capsules per bottle). The product is prescription-only and was manufactured for Trigen Laboratories, Inc. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product was distributed to Florida, Georgia, and South Carolina between February 23, 2021, and March 10, 2021. The source text does not specify which specific lot numbers are affected, only that all lots distributed during this period are included.

Consumers with this product should contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement. No illnesses or injuries have been reported in the source text.

The recalled product

Product
Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Supplement
Hazard
Affected units
80

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.

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Same hazard · temperature excursion

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