The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0852-2023·Announced 2023-06-07

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

Related recalls

Same manufacturer · Akorn, Inc.

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Same hazard · stability unverified

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