FDA Drug recall D-0545-2024
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane…
- FDA Drug
- Class II
- completed
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class II recall of Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane… by Winder Laboratories, citing product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0545-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-05-28 |
| Published | 2024-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Winder Laboratories |
| Distribution | US |
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
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Identifiers
| ndc | 75826-114-10 |
|---|---|
| ndc | 75826-115-10 |
| code_info | Lot#: 1142404 Exp. Date 02/27/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0545-2024%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.