Trihexyphenidyl Hydrochloride Oral Solution Recalled for Unverified Stability
All lots of Trihexyphenidyl Hydrochloride Oral Solution (2mg/5mL) distributed nationwide have been recalled. The manufacturer went out of business and could not complete stability studies needed to verify the drug's safety over time.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall, indicating potential for harm. However, no illnesses or injuries have been reported. The hazard is theoretical—the inability to verify drug stability due to incomplete manufacturing studies—not a confirmed product defect or contamination.
Plain-English summary
The FDA has issued a Class II recall for all lots of Trihexyphenidyl Hydrochloride Oral Solution, USP, 2 mg/5 mL, distributed by VersaPharm, Inc. (an Akorn Company) nationwide and in Puerto Rico. The recall is due to manufacturing practice deviations.
The manufacturer, Akorn, Inc., went out of business and was unable to continue stability studies required to demonstrate that the medication remains safe and effective over its shelf life. Without completed stability data, the agency cannot verify that the drug maintains its safety and efficacy throughout its intended use period.
If you have this medication, contact your healthcare provider or pharmacist for guidance on whether to continue using it or switch to an alternative. Do not stop taking necessary medications without medical advice. Return any unused product to your pharmacy for proper disposal.
The recalled product
- Product
- Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- Lake Forest, IL 60045. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Oral Solution
- Hazard
- stability-unverified
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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