Phenazopyridine HCl Tablets USP recall
FDA recall D-0545-2024 · initiated May 28, 2024
Winder Laboratories, LLC recalled Phenazopyridine HCl Tablets USP in May 2024 — an FDA Class II recall (D-0545-2024) because Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 473 cases (5676 Bottles)
Details
- 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,
- Recalling company
- Winder Labs LLC
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- May 28, 2024
- FDA report date
- Jun 19, 2024
Frequently asked
- Was Phenazopyridine HCl Tablets USP recalled?
- Winder Laboratories, LLC recalled Phenazopyridine HCl Tablets USP in May 2024 — an FDA Class II recall (D-0545-2024) because Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Phenazopyridine HCl Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0545-2024 was: Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Is a recalled Phenazopyridine HCl Tablets USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Phenazopyridine HCl Tablets USP are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot#: 1142404 Exp. Date 02/27/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0545-2024.