The Recall Desk
ModerateFDA (Drugs)·D-0507-2021·Announced 2021-06-02

Cardinal Health Recalls NOHIST DM Due to Temperature Excursions

Cardinal Health is recalling NOHIST DM antihistamine and decongestant liquid 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 due to CGMP deviations (temperature excursions) without reported injuries or illnesses, fitting the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Cardinal Health Inc. is recalling 24 bottles of NOHIST DM (Chlorpheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride) 16 fl. oz. (473 mL). The product is an over-the-counter antihistamine, antitussive, and nasal decongestant. The recall is being conducted due to CGMP deviations involving intermittent exposure to temperature excursions during storage.

The affected product is distributed by Larken Laboratories, Inc. in Canton, MS. The recall includes all lots distributed between February 23, 2021, and March 10, 2021. The product was distributed in Florida, Georgia, and South Carolina.

Consumers who have this product should stop using it and contact their pharmacist or physician for advice. The FDA classifies this recall as Class II, meaning there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
NOHIST DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE)
Brand
NOHIST DM
Affected units
24

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.

UPCs (1)

  • 0368047186164

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 →