Phenazopyridine recalls

The FDA has published 5 recalls involving Phenazopyridine since 2016. The latest was reported on 19 Jun 2024. Most were for potency & assay. Burel Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls5since 2016

Last 12 months0reported

Class I00% of total

Ongoing0latest 19 Jun 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 5 100%Class III 0 0%

Why phenazopyridine is recalled

Potency & Assay480%
Other Reasons120%

Companies

By year

2024120%
2016480%

All phenazopyridine recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
19 Jun 2024Drug	CLASS II	Phenazopyridine HCl Tablets USP, 100 mg recalled by Winder LaboratoriesPhenazopyridine Hydrochloride	Winder Laboratories	Other	Nationwide
7 Dec 2016Drug	CLASS II	Phenazopyridine Hydrochloride Tablets, USP, 100 mg recalled	Nationwide Laboratories	Potency & Assay	Nationwide
7 Dec 2016Drug	CLASS II	Phenazopyridine Hydrochloride Tablets, USP, 100 mg recalled	Burel Pharmaceuticals	Potency & Assay	Nationwide
7 Dec 2016Drug	CLASS II	Phenazopyridine Hydrochloride Tablets, USP, 200 mg recalled	Burel Pharmaceuticals	Potency & Assay	Nationwide
7 Dec 2016Drug	CLASS II	Phenazopyridine Hydrochloride Tablets, USP, 200 mg recalled	Nationwide Laboratories	Potency & Assay	Nationwide

Should you stop taking Phenazopyridine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.