CLASS IIDrug recall · Reported 9 Feb 2022 · FDA Enforcement Report
Cystex Urinary Pan Relief (Nsaid) (methenamine 162mg recalled
Ultra Seal is recalling Cystex Urinary Pan Relief (Nsaid) (methenamine 162mg, sodium salicylate 162.5mg tablets), distributed nationwide in the US. The recall was initiated on 24 Jan 2022 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codesLot #: 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
NDC69693-512
UPC0889476512480
Quantity recalleda) 702,240 blisters, b) 30,180 blisters
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations
Product as listed by the FDA
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
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
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.