Class II · Moderate risk
Phenazopyridine HCl
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Is Phenazopyridine recalled?
Not under an active recall.
Phenazopyridine was recalled 6 times in the past — all now closed. Most recent: May 31, 2024.
Most common reason: Wrong potency / content (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phenazopyridine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Phenazopyridine recalls on record
none so far in 2026; 6 on record, newest first
Class II · Moderate risk
Phenazopyridine HCl Tablets USP
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
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