Akorn Atropine Sulfate Eye Solution Recalled for Failed Stability Testing
Akorn is recalling 45,117 bottles of Atropine Sulfate Ophthalmic Solution because stability testing found viscosity measurements out of specification. The affected product should not be used.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 an FDA Class III recall involving a manufacturing quality defect—viscosity measurement failure during stability testing. No illnesses or injuries have been reported. Class III recalls typically score 1-2; this is scored 2 because it represents an actual product stability failure rather than a documentation or packaging-only issue.
Plain-English summary
Akorn, Inc. is recalling 45,117 bottles of Atropine Sulfate Ophthalmic Solution, USP 1%, a sterile prescription eye medication supplied in 2 mL bottles. The affected product was distributed nationwide in the USA and Puerto Rico.
The recall was initiated following stability testing that identified viscosity measurements falling out of specification at the 12-month stability timepoint. The affected lot is 081031A with an expiration date of 2/28/2023.
A recall means the product does not meet required quality standards. Persons who have received this medication should consult with their healthcare provider regarding appropriate action with the affected product.
The recalled product
- Product
- Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 45,117
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: 081031A
- Exp 2/28/2023
Distribution
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