Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Nortriptyline HCL capsules Recalled by Direct Rx Due to cGMP deviations: The quantity of active ingredient used...

Date: March 2, 2021
Company: Direct Rx
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 Direct Rx directly.

Affected Products

Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330

Quantity: 17 bottles

Why Was This Recalled?

cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.

Where Was This Sold?

This product was distributed to 1 state: GA

Affected (1 state)Not affected

About Direct Rx

Direct Rx has 36 total recalls tracked by RecallDetector.

Related Recalls

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