CLASS II Drug recall · Reported 7 Dec 2016 · FDA Enforcement Report
Phenazopyridine Hydrochloride Tablets, USP, 200 mg recalled
Burel Pharmaceuticals is recalling Phenazopyridine Hydrochloride Tablets, USP, 200 mg, distributed nationwide in the US. The recall was initiated on 24 Oct 2016 and the FDA has classified it as Class II.
Check your package
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.
Recall details
- Recall number
- D-0162-2017
- FDA event ID
- 75566
- Recalling firm
- Burel Pharmaceuticals, Richland, MS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Oct 2016
- FDA classified
- 29 Nov 2016
- Reported
- 7 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 24 Oct 2016 | Recall initiated by company | |
| 29 Nov 2016 | Classified by FDA | +36 days |
| 7 Dec 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Which lots are affected?
Lot #: 28181601, EXP 1/18; 28181603, EXP 5/18; 28181604, EXP 5/18; 28181605, EXP 5/18; 28181606, EXP 6/18; 28181607, EXP 5/18
Where was it sold?
Nationwide
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.
Other products in this recall event
7 other products · FDA event 75566More recalls from Burel Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Urolet MB Urinary Antiseptic, Antispasmodic Tablets recalled | Burel Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Urophen MB Urinary Antiseptic Tablets, Each tablet contains recalled | Burel Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Indiomin MB Urinary Antiseptic, Antispasmodic Capsules recalled | Burel Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Hyolev MB Urinary Antiseptic Tablets, Each tablet recalled | Burel Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Uramit MB Urinary Antiseptic Capsules recalled by Burel Pharmaceuticals | Burel Pharmaceuticals | Potency & Assay | Nationwide |
Other Phenazopyridine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenazopyridine HCl, 100mg tablets recalled by RemedyRepack | RemedyRepack | Packaging Defects | PA |
| Drug | CLASS II | Phenazopyridine HCl Tablets USP, 100 mg recalled by Winder LaboratoriesPhenazopyridine Hydrochloride | Winder Laboratories | Other | Nationwide |
| Drug | CLASS II | Phenazopyridine Hydrochloride Tablets, USP, 100 mg recalled | Nationwide Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenazopyridine Hydrochloride Tablets, USP, 100 mg recalled | Burel Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenazopyridine Hydrochloride Tablets, USP, 200 mg recalled | Nationwide Laboratories | Potency & Assay | Nationwide |