Phenazopyridine HCl recall
FDA recall D-0549-2024 · initiated May 31, 2024
RemedyRepack Inc. recalled Phenazopyridine HCl in May 2024 — an FDA Class II recall (D-0549-2024) because Product Mix Up. A bottle labeled as 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 labeled as 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: 8 bottles
Details
- 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
- Recalling company
- RemedyRepack Inc.
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to one medical facility.
- Initiated
- May 31, 2024
- FDA report date
- Jun 19, 2024
Frequently asked
- Was Phenazopyridine HCl recalled?
- RemedyRepack Inc. recalled Phenazopyridine HCl in May 2024 — an FDA Class II recall (D-0549-2024) because Product Mix Up. A bottle labeled as 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 recalled?
- Per the FDA enforcement record, the reason for recall D-0549-2024 was: Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Is a recalled Phenazopyridine HCl 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 are affected?
- Distributed: Product was distributed to one medical facility.. The recall covers these lots — Lot # B2906961-042524, exp. date 02/26/2027. 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-0549-2024.