FDA Recall of Albuterol Sulfate Inhalation Solution Due to Illegible Labels
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Nephron SC, LLC is recalling 146,280 vials of Albuterol Sulfate Inhalation Solution because of illegible labels, affecting products distributed nationwide in the United States.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Nephron SC, LLC is voluntarily recalling Albuterol Sulfate Inhalation Solution due to issues with illegible labels, as initiated on March 17, 2026.
Which Products Are Affected
The affected product is Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, with NDC 69374-330-05. This recall involves 146,280 vials from lot AB6001, with an expiration date of January 15, 2027. The products were distributed nationwide within the United States, and the recall number is D-0479-2026.
What You Should Do
Consumers should contact the recalling firm, Nephron SC, LLC at 4500 12th Street Ext, West Columbia, SC 29172-3025, for information on returns or refunds, as this is a voluntary recall.
Why This Matters
This recall addresses potential risks from illegible labels on a prescription drug, which could lead to medication errors; it is classified as Class II, indicating a remote probability of serious health consequences.
Source
Attribution: FDA. For more information, refer to the FDA recall details under event ID 98596.
Original source: FDA Official Notice ↗
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