Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Hyoscyamine Sulfate Recalled by VIRTUS PHARMACEUTICALS OPCO II L Due to Failed Content Uniformity Specifications: resulting in both superpotent...

Date: September 2, 2016
Company: VIRTUS PHARMACEUTICALS OPCO II L
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact VIRTUS PHARMACEUTICALS OPCO II L directly.

Affected Products

Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.

Quantity: 94,643 bottles

Why Was This Recalled?

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About VIRTUS PHARMACEUTICALS OPCO II L

VIRTUS PHARMACEUTICALS OPCO II L has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report