FDA Drug recall D-0549-2024
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source ND…
- FDA Drug
- Class II
- terminated
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class II recall of Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source ND… by Remedyrepack, citing product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0549-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-05-31 |
| Published | 2024-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Remedyrepack |
| Distribution | n/a |
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.
Identifiers
| code_info | Lot # B2906961-042524, exp. date 02/26/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0549-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.