CLASS II Drug recall · Reported 19 Jun 2024 · FDA Enforcement Report
Phenazopyridine HCl, 100mg tablets recalled by RemedyRepack
RemedyRepack is recalling Phenazopyridine HCl, 100mg tablets. The recall was initiated on 31 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-0549-2024
- FDA event ID
- 94738
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 May 2024
- FDA classified
- 10 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 31 May 2024 | Recall initiated by company | |
| 10 Jun 2024 | Classified by FDA | +10 days |
| 19 Jun 2024 | Published in enforcement report | +9 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 labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Product was distributed to one medical facility.
Questions about this recall
Is Phenazopyridine HCl, 100mg tablets recalled?
Yes. RemedyRepack recalled Phenazopyridine HCl, 100mg tablets on 31 May 2024. The recall is Class II and its status is Terminated. Recall number D-0549-2024.
Why was it recalled?
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Which lots are affected?
Lot # B2906961-042524, exp. date 02/26/2027
Where was it sold?
Product was distributed to one medical facility.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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