Akorn Atropine Sulfate Eye Drops Recalled Due to Manufacturing Compliance Failures
Akorn, Inc. is recalling all lots of Atropine Sulfate Ophthalmic Solution USP 1% because the firm went out of business and could not complete required stability studies. The product was distributed nationwide in the USA and Puerto Rico.
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: FDA Class II recall with no reported illnesses, injuries, or deaths. The recall is precautionary due to the manufacturer's inability to complete required stability studies; no evidence of actual product contamination or defect is cited in the source.
Plain-English summary
Akorn, Inc. is recalling all lots of Atropine Sulfate Ophthalmic Solution USP 1% (an eye drop medication) packaged in 2 mL, 5 mL, and 15 mL bottles distributed by Akorn Operating Company LLC. The product was distributed nationwide in the USA and Puerto Rico.
The firm initiated this recall because it went out of business and could no longer continue the stability studies required by U.S. Food and Drug Administration regulations. These studies are essential to confirm that the product remains safe, effective, and stable under various storage conditions throughout its shelf life.
Patients currently using this product should consult their prescribing physician or pharmacist about alternative treatments. Healthcare providers should contact Akorn or their distributors to identify affected lots. Unused product should not be discarded in trash or flushed down drains; consumers should contact their pharmacist or local hazardous waste facility for proper disposal.
The recalled product
- Product
- Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic / Eye Drops
- Hazard
- 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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