Phenazopyridine HCl Tablets USP — Class II drug recall D-0545-2024
Completed recall by Winder Laboratories, LLC, reported 2024-06-19, distributed nationwide. Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
| Recall number | D-0545-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Winder Laboratories, LLC, Winder, GA, United States |
| Recall initiated | 2024-05-28 |
| Classified | 2024-06-07 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| NDC | 75826-0114, 75826-0114-10, 75826-0115, 75826-0115-10 |
| Lot numbers | 1142404 |
| Expiration dates | 2027-02-27 |
Product
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,
Reason for recall
Product Mix Up. A bottle of 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-0545-2024. 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.