Class II — Potential Health Hazard

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

Cystex Tablet (Sodium Salicylate 162.5 mg Recalled by ULTRAtab Laboratories, Inc. Due to CGMP Deviations

Date: January 26, 2022
Company: ULTRAtab Laboratories, Inc.
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 ULTRAtab Laboratories, Inc. directly.

Affected Products

Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00

Quantity: 37,464,418 tablets

Why Was This Recalled?

CGMP Deviations

Where Was This Sold?

Bulk product was distributed to 3 distributors who may have distributed finished product.

About ULTRAtab Laboratories, Inc.

ULTRAtab Laboratories, Inc. has 43 total recalls tracked by RecallDetector.

Related Recalls

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