Class II · Moderate risk
Cystex Tablet
CGMP Deviations
Is Methenamine recalled?
Not under an active recall.
Methenamine was recalled 12 times in the past — all now closed. Most recent: Jan 26, 2022.
Most common reason: Wrong potency / content (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Methenamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Methenamine recalls on record
none so far in 2026; 12 on record, newest first
Class II · Moderate risk
Cystex Urinary Pan Relief
cGMP deviations
Class II · Moderate risk
VILEVEV MB Urinary Antispetic
cGMP deviations
Class II · Moderate risk
Vilamit Mb
cGMP deviations
Class II · Moderate risk
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.
Class II · Moderate risk
Indiomin MB URINARY ANTISEPTIC
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
AZUPHEN MB URINARY ANTISEPTIC Capsules
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
UROPHEN MB URINARY ANTISEPTIC Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
URAMIT MB URINARY ANTISEPTIC Capsules
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Urolet Mb Urinary Antiseptic
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Hyolev MB URINARY ANTISEPTIC Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Methenamine/Phenyl Salicylate Capsule
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
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