The Recall Desk
ModerateFDA (Drugs)·D-0783-2023·Announced 2023-06-07

Albuterol Sulfate Syrup Recalled for Incomplete Stability Studies

Akorn, Inc. is recalling all lots of Albuterol Sulfate Syrup nationwide due to CGMP deviations. The firm went out of business and could not complete required stability studies to verify ongoing product safety and effectiveness.

What this means for you

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 an FDA Class II precautionary recall with no reported illnesses or injuries and no confirmed product defects. The issue is incomplete stability studies due to firm closure, making this a compliance matter rather than an identified product hazard. The theoretical nature of the hazard and lack of reported harm place this at Moderate severity.

Plain-English summary

Akorn, Inc. is recalling all lots of Albuterol Sulfate Syrup (2 mg base, 16 fl oz per bottle) distributed nationwide in the USA and Puerto Rico. The recall affects all NDC codes for this medication.

The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations. Specifically, the firm went out of business and could no longer continue ongoing stability studies required to verify that the product remains safe and effective throughout its shelf life.

Patients using this medication should not stop their treatment without consulting their healthcare provider. Those who have this product should speak with their pharmacist or physician about whether they have affected stock and what alternatives may be available.

Healthcare providers and pharmacists with questions should contact the recalling firm or the FDA.

The recalled product

Product
Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Respiratory
Hazard
  • stability-unverified
  • cgmp-deviation

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)

  • All Lots

Distribution

Distributed nationwide across the United States.

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