Timolol Maleate eye drops recalled for unknown impurity in stability testing
Akorn, Inc. is recalling Timolol Maleate Ophthalmic Solution due to identification of an unknown impurity during 12-month stability testing. No illnesses have been reported.
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 III recall with no reported illnesses or injuries. The hazard is a documented quality failure detected during stability testing, but it remains precautionary in nature without evidence of adverse effects in distributed product.
Plain-English summary
Akorn, Inc. is recalling Timolol Maleate Ophthalmic Solution, USP, 0.5%, supplied in 5 x 0.3 mL single-dose vials nationwide. The recall affects Lot #9N72 with expiration date 09/30/2022 due to the identification of an unknown impurity at the 12-month stability testing point.
The impurity was detected during routine stability testing, which assesses whether a pharmaceutical product maintains its quality throughout its shelf life. The presence of an unknown substance does not meet the product's established specifications.
Patients currently using the recalled lot should consult their healthcare provider or pharmacist. Do not stop using the medication without medical guidance, as interrupting timolol use may affect eye health. Patients should return unused portions to their pharmacy or follow local medication disposal guidelines.
No illnesses or adverse effects have been reported in connection with this recall. The FDA is monitoring the situation and additional information will be provided as it becomes available.
The recalled product
- Product
- Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
- Manufacturer
- Akorn, Inc
- Category
- Drug — Ophthalmic Solution
- Hazard
- unknown-impurity
- degradation
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 #: 9N72
- EXP 09/30/2022
Distribution
Distributed nationwide across the United States.
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