CLASS II Drug recall · Reported 19 Jun 2024 · FDA Enforcement Report
Phenazopyridine HCl Tablets USP, 100 mg recalled by Winder Laboratories
Winder Laboratories is recalling Phenazopyridine HCl Tablets USP, 100 mg, distributed nationwide in the US. The recall was initiated on 28 May 2024 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-0545-2024
- FDA event ID
- 94727
- Recalling firm
- Winder Laboratories, Winder, GA
- Manufacturer
- Winder Laboratories, LLC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 28 May 2024
- FDA classified
- 7 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
Timeline
| 28 May 2024 | Recall initiated by company | |
| 7 Jun 2024 | Classified by FDA | +10 days |
| 19 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Product as listed by the FDA
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Which lots are affected?
Lot#: 1142404 Exp. Date 02/27/2027
Where was it sold?
Nationwide within the United States
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.
More recalls from Winder Laboratories
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS III | Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx recalledMultivitamin | Winder Laboratories | Potency & Assay | 25 states |
| Drug | CLASS III | Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine Sulfate | Winder Laboratories | Packaging Defects | 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 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 | Burel Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenazopyridine Hydrochloride Tablets, USP, 200 mg recalled | Nationwide Laboratories | Potency & Assay | Nationwide |