Prescription drug

Where is Phenazopyridine made?

10 companies sell it under their own name and 23 repackagers rebottle it. Their labels name 3 factories in the United States.

United States 3

Companies and their factories

Company on the label	Factory	Where	Last FDA inspection
Winder Laboratories, LLC100 mg, 200 mg · NDC 75826-114, 75826-115	PureTek CorporationMakes it	San Fernando, CA, United States	Problems found, fixed voluntarilyMar 2025
	Winder Laboratories, LLCMakes it	Winder, GA, United States	Serious problems, FDA actionAug 2025
Amneal Pharmaceuticals100 mg, 200 mg · NDC 65162-517, 60846-501, 65162-681 +3	Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it	Hauppauge, NY, United States	No problems foundFeb 2020
Chartwell RX, LLC.100 mg, 200 mg · NDC 62135-403, 62135-404	The label doesn't name the factory. Plants this company names for other drugs
Genus Lifesciences Inc.100 mg, 200 mg · NDC 64950-550, 64950-551	The label doesn't name the factory. Plants this company names for other drugs
Graxcell Pharmaceutical, Llc.100 mg, 200 mg · NDC 70795-1241, 70795-1252	The label doesn't name the factory. Plants this company names for other drugs
Marlex Pharmaceuticals, Inc.100 mg, 200 mg · NDC 10135-620, 10135-621	The label doesn't name the factory. Plants this company names for other drugs
Pageview Pharmaceuticals100 mg, 200 mg · NDC 73028-201, 73028-202	The label doesn't name the factory. Plants this company names for other drugs
Skya Health, LLC100 mg, 200 mg · NDC 73086-101, 73086-102	The label doesn't name the factory. Plants this company names for other drugs
Vilvet Pharmaceuticals Inc100 mg, 200 mg · NDC 71186-003, 71186-004	The label doesn't name the factory. Plants this company names for other drugs
Westminster Pharmaceuticals, LLC100 mg, 200 mg · NDC 69367-611, 69367-612	The label doesn't name the factory. Plants this company names for other drugs

Repackaged by

These companies buy Phenazopyridine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.

A-S Medication Solutions: 50090-6442, 50090-7291, 50090-4318, 50090-2708 +8
Aidarex Pharmaceuticals LLC: 33261-132, 53217-178, 33261-150, 53217-174
Apotheca, Inc.: 12634-189
Blenheim Pharmacal, Inc.: 10544-115, 10544-055, 10544-571, 10544-077
Bryant Ranch Prepack: 71335-2184, 71335-0898, 71335-2323, 71335-9712 +5
Carilion Materials Management: 68151-1992
Denton Pharma, Inc. DBA Northwind Pharmaceuticals.: 70934-740
Direct Rx: 72189-047, 61919-216, 72189-515, 72189-534 +7
H.J. Harkins Co., Inc.: 52959-122
Liberty Pharmaceuticals, Inc.: 0440-2070
MedVantx, Inc.: 66116-484
Northwind Pharmaceuticals: 51655-007, 51655-424
NuCare Pharmaceuticals.Inc.: 68071-2357, 68071-5302, 68071-5309, 68071-3533 +2
PD-Rx Pharmaceuticals, Inc.: 72789-362, 72789-288
Preferred Pharmaceuticals, Inc..: 68788-9501, 68788-7981, 68788-8668, 68788-9537 +2
Proficient Rx LP: 82804-047, 82804-994, 82804-192, 71205-813 +3
RPK Pharmaceuticals, Inc.: 53002-3152, 53002-3150, 53002-3151
ReadyMeds: 64205-520
Rebel Distributors Corp..: 21695-638, 21695-301
RedPharm Drug. Inc.: 67296-0598, 67296-1295, 67296-1231, 67296-1177 +10
Remedyrepack Inc.: 70518-3986, 70518-0218, 70518-3443, 70518-3975 +1
Unit Dose Services: 50436-0450, 50436-4388
Verityrx, LLC: 83939-0021

Recalls

May 31, 2024 · Class II · RemedyRepack Inc.
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
May 28, 2024 · Class II · Winder Laboratories, LLC
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.