The Recall Desk
ModerateFDA (Drugs)·D-0475-2021·Announced 2021-06-02

Cardinal Health Recalls Prenatal Tablets Due to Temperature Excursions

Cardinal Health is recalling 41 bottles of prenatal tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

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 theoretical risk of product degradation due to temperature excursions, fitting the criteria for a moderate severity score.

Plain-English summary

Cardinal Health Inc. is recalling 41 bottles of Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women (NDC 77333-715-10). The recall was initiated 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.

Consumers who have this product should stop using it and contact Cardinal Health Inc. for further instructions or a refund.

The recalled product

Product
Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals
Affected units
41

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 →