The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0471-2022·Announced 2022-02-09

CYSTEX Urinary Pain Relief tablets recalled for cGMP deviations

Ultra Seal Corporation is voluntarily recalling CYSTEX Urinary Pain Relief tablets nationwide due to cGMP (current good manufacturing practice) deviations. The recall affects specific lot numbers distributed in 40-count and 20-count blister packages.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall initiated voluntarily by the firm for manufacturing deviations (cGMP violations). The source text does not report any illnesses, injuries, or hospitalizations associated with this recall, making it a precautionary action. Per the rubric, such recalls are typically classified as Moderate.

Plain-English summary

Ultra Seal Corporation, through distributor Clarion Brands LLC, is voluntarily recalling CYSTEX Urinary Pain Relief (methenamine 162 mg, sodium salicylate 162.5 mg) tablets due to cGMP deviations identified during manufacturing.

The affected products are packaged in two formats: 40-count blisters (lot numbers 19A043, 19A093, 19B062, 19C079, 19C080, 19D041, 19E035, 19E087, 19G084, 19H098, with expiration dates ranging from 01/2022 to 09/2022) and 20-count blisters (lot number 19H098A, expiration date 09/2022). A total of 702,240 units of the 40-count format and 30,180 units of the 20-count format have been distributed nationwide within the United States.

Consumers who have purchased affected lots should stop using the product. Consumers with questions may contact the recalling firm or their healthcare provider. The FDA has classified this as a Class II recall. The firm voluntarily initiated the recall on January 24, 2022, and the recall was terminated on October 16, 2023.

The recalled product

Product
CYSTEX (METHENAMINE, SODIUM SALICYLATE)
Brand
CYSTEX
Manufacturer
Ultra Seal Corporation
Category
Drug — OTC Urinary Health
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 (17)

  • Lot #: a) 19A043
  • 19A093
  • Exp. Date 01/2022
  • 19B062
  • 19C079
  • 19C080
  • Exp. Date 03/2022
  • 19D041
  • Exp. Date 04/2022
  • 19E035
  • 19E087
  • Exp. Date 05/2022
  • 19G084
  • Exp. Date 08/2022
  • 19H098
  • Exp. Date 09/2022 b) 19H098A
  • Exp. Date 09/2022

UPCs (1)

  • 0889476512480

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 recalled by Ultra Seal Corporation 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 56 products in this recall →

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