Phenazopyridine HCl — Class II drug recall D-0549-2024
Terminated recall by RemedyRepack Inc., reported 2024-06-19. Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.
| Recall number | D-0549-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2024-05-31 |
| Classified | 2024-06-10 |
| Reported by FDA | 2024-06-19 |
| Terminated | 2024-07-01 |
| Quantity | 8 bottles |
| Reason classes | labeling |
| NDC | 70518-0218-00, 75826-0114-10 |
| Lot numbers | B2906961-042524 |
| Expiration dates | 2027-02-26 |
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 for recall
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0549-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.