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Stop using now Drug recall · FDA · Published May 31, 2024

RemedyRepack recalls Phenazopyridine tablets with wrong medication mix-up

RemedyRepack recalls 100mg Phenazopyridine tablets that were mistakenly repackaged with Phenobarbital. This mix-up could cause serious harm if taken by mistake.

🇺🇸 FDA recall #D-0549-2024DrugRemedyRepack ›
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Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571
✎ GovInfoNow plain-language explainer

What happened, in plain English

RemedyRepack is recalling 100mg Phenazopyridine HCl tablets that were repackaged with Phenobarbital tablets instead. This mix-up could cause serious harm if someone takes the wrong medication. Read more at govinfonow.com/recall/32639-remedyrepack-recalls-phenazopyridine-tablets-with-wrong-medication-mix-up.

Source Summary by GovInfoNow · govinfonow.com/recall/32639-remedyrepack-recalls-phenazopyridine-tablets-with-wrong-medication-mix-up · Updated August 17, 2026 · FDA enforcement record: FDA #D-0549-2024

Cite this page

“RemedyRepack recalls Phenazopyridine tablets with wrong medication mix-up.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32639-remedyrepack-recalls-phenazopyridine-tablets-with-wrong-medication-mix-up. Based on FDA recall #D-0549-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0549-2024%22&limit=1).

Why it’s dangerous

The product was repackaged incorrectly, containing Phenobarbital tablets (a different medication) instead of Phenazopyridine HCl. Phenobarbital is a sedative that can cause serious harm or death if taken by mistake.

Who’s affected

People who have the 6-count bottles of Phenazopyridine HCl 100mg tablets repackaged by RemedyRepack Inc. are affected. Those who may have taken the tablets by mistake are at highest risk.

How to tell if you have this one

Check for 6-count bottles labeled 'Phenazopyridine HCl, 100mg' repackaged by RemedyRepack Inc. in the US. The NDC number 70518-0218-00 or source NDC 75826-0114-10 may help identify the product.

  • Brand
    RemedyRepack
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop using it now

    Immediately stop using the recalled tablets and do not take them.

How this recall unfolded

Recall timeline

FDA terminated this recall 31 days after the firm started it.

1. Firm started the recall: May 31, 202412. FDA classified it Class II: Jun 10, 202423. Published in FDA’s Enforcement Report: Jun 19, 202434. FDA terminated the recall: Jul 1, 202442024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0549-2024 (May 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0549-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA