Burel Recalls Phenazopyridine Tablets Due to CGMP Deviations
Burel Pharmaceuticals recalls 35,149 bottles of Phenazopyridine Hydrochloride Tablets due to manufacturing deficiencies that may affect drug potency and safety.
Use caution until it’s fixed
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Contact the company
What happened, in plain English
Burel Pharmaceuticals Inc is recalling Phenazopyridine Hydrochloride Tablets, USP, 200 mg in 100-count bottles. The recall addresses Current Good Manufacturing Practice (CGMP) deviations at the manufacturer which could lead to assay or content uniformity failures. This means the amount of active ingredient in the tablets might not be consistent with what is labeled. Read more at govinfonow.com/recall/42276-burel-recalls-phenazopyridine-tablets-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/42276-burel-recalls-phenazopyridine-tablets-due-to-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-0162-2017
Cite this page
“Burel Recalls Phenazopyridine Tablets Due to CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42276-burel-recalls-phenazopyridine-tablets-due-to-cgmp-deviations. Based on FDA recall #D-0162-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0162-2017%22&limit=1).
Why it’s dangerous
The manufacturer's deficiencies may result in the tablets having incorrect amounts of the active ingredient (assay or content uniformity failures). This inconsistency can lead to ineffective treatment if the dose is too low or potential side effects if the dose is too high, although specific injury details are not provided.
Who’s affected
Patients who have purchased Phenazopyridine Hydrochloride Tablets, USP, 200 mg bottles manufactured by Burel Pharmaceuticals. Individuals relying on this medication for urinary tract symptoms are most at risk of receiving a product with inconsistent potency.
How to tell if you have this one
Check your bottle for the brand Burel Pharmaceuticals. Look for NDC 35573-306-10 and verify the lot number against: 28181601 (EXP 1/18), 28181603 (EXP 5/18), 28181604 (EXP 5/18), 28181605 (EXP 5/18), 28181606 (EXP 6/18), or 28181607 (EXP 5/18). The product was distributed nationwide.
- Brand
Burel Pharmaceuticals- Category
Drug
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0155-2017 | Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90; LOT # 29001501, EXP 07/17 | 2861 bottles |
| D-0156-2017 | UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS; (a) LOT # 28981501, EXP 8/17, NDC 35573-302-30; (b) LOT # 28981501, EXP 8/17, LOT # 28981601, EXP 4/18, NDC 35573-302-10 | 11,539 bottles |
| D-0157-2017 | URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-300-10; LOT # 28751601, exp 8/18 | 2,771 bottles |
| D-0158-2017 | UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10; LOT # 29131501, EXP 9/17 | 823 bottles |
| D-0159-2017 | AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10; LOT # 29421501, EXP 10/17 | 604 bottles |
| D-0160-2017 | Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10; LOT # 29401501, EXP 10/17 | 795 bottles |
| D-0161-2017 | Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10; Lot #: 28161601, EXP 1/18; 28161603, EXP 5/18; and 28161604, EXP 6/18 | 17,788 bottles |
| D-0162-2017 | Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10; 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 | 35,149 bottles |
What to do — step by step
Check Your Bottle
Verify if your bottle matches the NDC 35573-306-10 and one of the listed lot numbers with their corresponding expiration dates.
Contact Healthcare Provider
Consult your doctor or pharmacist regarding the recall and whether you should continue using the medication or switch to an alternative.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the expiration date for these recalled lots?
The expiration dates range from January 2018 to June 2018 depending on the specific lot number.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0162-2017 (October 24, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0162-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.