---
title: "Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: ... — FDA record D-0549-2024 | Is It on Recall"
description: "Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg."
url: https://isitonrecall.com/recall/fda-drug-d-0549-2024-phenazopyridine-hcl-100mg-tablets-6-count-bottles-rx-only-repackaged-by-remedyrepack-inc-indiana-pa/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70... — FDA record D-0549-2024

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 31, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA
- **Reason**: Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- **Classification**: Class II
- **Recalling firm**: RemedyRepack Inc.
- **Quantity**: 8 bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0549-2024

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0549-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot # B2906961-042524, exp. date 02/26/2027 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Product was distributed to one medical facility.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Jun 19, 2024
- **Recall initiation date**: May 31, 2024
- **Center classification date**: Jun 10, 2024
- **Termination date**: Jul 1, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0549-2024%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [RemedyRepack Inc. records](https://isitonrecall.com/brand/remedyrepack-inc/)