FDAClass IIApril 22, 2026

Albuterol Sulfate Inhalation Solution recall: Labeling Error

Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600…

Why was Albuterol Sulfate Inhalation Solution recalled?

Labelling: Illegible label

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot AB6001, exp date 1/15/2027

Product
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600…
Recalling firm
Nephron SC, LLC
Quantity
146,280 vials
Distribution
Nationwide within the United States
Recall date
April 22, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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