Winder Laboratories recalls Phenazopyridine tablets with phenobarbital mix-up
Winder Laboratories recalls 100-count Phenazopyridine HCl tablets USP 100 mg bottles due to accidental mix-up with phenobarbital tablets. Consumers should check product details and contact the manufacturer for guidance.
Recall notice
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Contact the company
What happened, in plain English
Winder Laboratories is recalling 100-count bottles of Phenazopyridine HCl tablets USP 100 mg (Rx only) because they accidentally mixed up with phenobarbital tablets. This mix-up could lead to taking the wrong medication, which may cause serious health issues. Read more at govinfonow.com/recall/32645-winder-laboratories-recalls-phenazopyridine-tablets-with-phenobarbital-mix-up.
Source Summary by GovInfoNow · govinfonow.com/recall/32645-winder-laboratories-recalls-phenazopyridine-tablets-with-phenobarbital-mix-up · Updated August 17, 2026 · FDA enforcement record: FDA #D-0545-2024
Cite this page
“Winder Laboratories recalls Phenazopyridine tablets with phenobarbital mix-up.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32645-winder-laboratories-recalls-phenazopyridine-tablets-with-phenobarbital-mix-up. Based on FDA recall #D-0545-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0545-2024%22&limit=1).
Why it’s dangerous
The recall is for a product mix-up where a bottle of Phenazopyridine HCl tablets USP 100 mg accidentally contained Phenobarbital tablets 16.2 mg. Phenobarbital is a different medication that can cause serious health risks if taken instead of phenazopyridine.
Who’s affected
People who have the 100-count bottles of Phenazopyridine HCl tablets USP 100 mg (Rx only) from Winder Laboratories are affected. Those who may have taken the phenobarbital tablets instead of phenazopyridine could be at risk.
How to tell if you have this one
Check for the product name 'Phenazopyridine HCl Tablets USP 100 mg', 100-count bottles, manufactured by Winder Laboratories, LLC, with NDC 75826-114-10 and lot number 1142404.
- Brand
Winder Laboratories- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 75826-114-10 and lot number 1142404 on the bottle to confirm if it's part of the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 22 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0545-2024 (May 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0545-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.