Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Jan 24, 2022 (5 years ago)

Cystex Urinary Pan Relief (Methenamine, Sodium Salicylate)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP deviations

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count blisters, Distributed by: Clarion Brands, LLC 27070 Miles Road, Suite A Solon, OH 44139, NDC 69693-512-40

Affected NDC 69693-0512-40

Compare with the code on your package — it is the most precise check available.

Drug: Methenamine

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Cystex Plus
methenamine, sodium salicylate
NDC 69693-0512		 METHENAMINE 162 mg/1; SODIUM SALICYLATE 162.5 mg/1 Tablet
Oral		 Clarion Brands, LLC OTC
Recalling firm
Ultra Seal Corporation
NDC code
69693-512-40
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0471-2022 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Methenamine recalls

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Class II · Moderate risk

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CGMP Deviations

Terminated cGMP deviation ULTRAtab Laboratories, Inc. D-0555-2022
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cGMP deviations

Terminated cGMP deviation Vilvet Pharmaceuticals Inc. NDC 71186-002-35 D-1487-2020
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Urin D/S Tablets Methenamine 81.6 mg

Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.

Terminated Wrong potency / content Llorens Pharmaceutical Corp. D-0081-2018

Other recalls by Ultra Seal Corporation

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Class II · Moderate risk

Sinus Relief

cGMP deviations

Terminated cGMP deviation Ultra Seal Corporation D-0518-2022