Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 50
Summary
The FDA issued a Class II for Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Ster by Nephron SC, LLC. Reason: Labelling: Illegible label.
Details
Source
Drug Recall
External ID
D-0479-2026
Action Date
2026-04-22
Status
Ongoing
Category
drug
Product Description
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 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
Lot/Code Info: Lot AB6001, exp date 1/15/2027
Quantity Affected: 146,280 vials
Reason for Recall
Labelling: Illegible label
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-17
Company
West Columbia, SC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 94 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nephron SC, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nephron SC, LLC have FDA actions?
This is the only FDA action we have on record for Nephron SC, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0479-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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