Prescription Drug Recall: Phenazopyridine Tablets Contain Wrong Medication
Winder Laboratories is recalling Phenazopyridine HCl tablets (Lot #1142404) due to a product mix-up where some bottles contain Phenobarbital tablets instead. No illnesses or injuries have been reported.
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 product mix-up where the wrong medication was dispensed. While no illnesses or injuries have been reported, the potential for serious harm exists because patients could inadvertently take an inappropriate medication. Per the rubric, risk-of-harm products where injury has not yet been reported warrant a score of 3.
Plain-English summary
Winder Laboratories, LLC is recalling Phenazopyridine HCl Tablets USP, 100 mg (100-count bottles, NDC 75826-114-10) due to a product mix-up. Some bottles labeled as Phenazopyridine HCl contain Phenobarbital tablets (16.2 mg) instead. The issue affects Lot #1142404, which expires 02/27/2027.
The affected bottles were distributed nationwide in the United States. This recall impacts patients who received prescriptions filled from this lot, as well as retail pharmacies and distributors that stocked the product.
Patients who have a bottle from Lot #1142404 should stop using it immediately and contact their pharmacy or physician. Do not take the tablets. Return the medication to the pharmacy. No illnesses or injuries have been reported to date.
The recalled product
- Product
- PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE HYDROCHLORIDE)
- Brand
- PHENAZOPYRIDINE HYDROCHLORIDE
- Manufacturer
- Winder Laboratories, LLC
- Category
- Drug — Prescription Medication
- Hazard
- wrong-medication
- product-mix-up
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 (1)
- Lot#: 1142404 Exp. Date 02/27/2027
UPCs (2)
- 0375826115109
- 0375826114102
Distribution
Distributed nationwide across the United States.
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