Phenazopyridine bottles recalled due to medication mix-up error
RemedyRepack Inc. is recalling bottles labeled as Phenazopyridine HCl 100mg that actually contain Phenobarbital 16.2mg tablets. Eight bottles were distributed to one medical facility. Patients should not use these medications and must contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a serious medication error where bottles labeled as one drug contain a different medication. No illnesses or injuries have been reported, making this a High (3) severity case consistent with the rubric's classification of risk-of-harm products where injury has not yet been reported.
Plain-English summary
RemedyRepack Inc. is recalling eight bottles of medication distributed to one medical facility. The bottles are labeled as Phenazopyridine HCl tablets USP 100mg, but instead contain Phenobarbital tablets 16.2mg.
This is a serious medication error. Patients receiving the incorrectly labeled bottles could be dispensed the wrong medication, which could affect their treatment. Phenazopyridine and Phenobarbital are different medications with different therapeutic uses and effects.
The affected product details: NDC# 70518-0218-00 (repackaged), source NDC 75826-0114-10, manufactured by Winder Laboratories, LLC, lot number B2906961-042524, expiration date February 26, 2027.
Patients who have received this medication should not use it and should contact their healthcare provider or pharmacist immediately. Medical facilities should quarantine and return the affected product to RemedyRepack Inc.
The recalled product
- 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
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug
- Hazard
- medication-error
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # B2906961-042524
- exp. date 02/26/2027
Distribution
Distribution scope not specified by the agency.
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