The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0176-2023·Announced 2023-02-01

Drug Recall: S2 Racepinephrine Inhalation Solution Short Fill

Nephron Sc Inc recalls approximately 925,920 vials of S2 Racepinephrine Inhalation Solution due to short fill. Affected lots may contain less medication than labeled.

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: This is a Class II voluntary recall with no reported illnesses or injuries. The hazard is short fill (underfill), which is a quality and dosing issue rather than contamination or direct safety hazard.

Plain-English summary

Nephron Sc Inc has recalled approximately 925,920 vials of S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator in 30 x 0.5 mL Sterile Unit-of-Use vials (NDC 0487-5901-99). The recall applies to Lot numbers 126461 and 126431 with expiration date 04/30/2023.

The recall was initiated due to short fill, meaning the vials contain less medication than the labeled quantity. This is a Class II recall initiated voluntarily by the manufacturer.

The affected vials were distributed nationwide within the United States, including Puerto Rico and Guatemala.

Patients and healthcare providers in possession of these vials should stop using them and contact Nephron Sc Inc for further instructions.

The recalled product

Product
S2 (RACEPINEPHRINE HYDROCHLORIDE)
Brand
S2
Manufacturer
Nephron Sc Inc
Category
Drug
Hazard
Affected units
925,920

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 (2)

  • Lot #: 126461
  • 126431 Exp. 04/30/2023

UPCs (1)

  • 304875901999

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Nephron Sc 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 2 products in this recall →

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