The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0473-2021·Announced 2021-06-02

Narcan Nasal Spray Recalled for Temperature Excursions During Storage

Cardinal Health is recalling Narcan (naloxone hydrochloride) nasal spray due to intermittent exposure to temperature excursions during storage.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, and the source text does not report any illnesses, injuries, or deaths. The hazard is a potential quality issue (temperature excursion) without confirmed harm, fitting the criteria for a moderate severity score.

Plain-English summary

Cardinal Health Inc. is recalling Narcan (naloxone hydrochloride) Nasal Spray 4 mg Two Pack. The recall involves 11,189 plungers of the product, which is distributed by Adapt Pharma, Inc. The affected units were distributed in Florida, Georgia, and South Carolina.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product experienced intermittent exposure to temperature excursions during storage. This condition may affect the stability or quality of the medication.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is a prescription drug intended for intranasal use only.

The recalled product

Product
NARCAN (NALOXONE HYDROCHLORIDE)
Brand
NARCAN
Manufacturer
Cardinal Health Inc.
Category
Drug — Nasal Spray
Hazard
Affected units
11,189

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)

  • 201701

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 →

Similar recalls