Medications & Supplements/Prescription Drugs

Phenazopyridine HCl Tablets Recalled Due to Phenobarbital Mix-Up

Agency Publication Date: June 7, 2024

Summary

Winder Laboratories, LLC is recalling one lot of Phenazopyridine HCl (a urinary pain medication) because a bottle was found to contain Phenobarbital (a sedative). The recall affects 473 cases (5676 Bottles) of 100-count bottles. Taking Phenobarbital accidentally instead of the intended medication can cause dangerous side effects like extreme drowsiness or breathing difficulties.

Risk

Phenobarbital is a controlled substance that acts as a central nervous system depressant. Unintentionally consuming Phenobarbital instead of the intended urinary medication poses a risk of toxicity, severe sedation, and potentially dangerous drug interactions.

What You Should Do

This recall affects 100-count bottles of Phenazopyridine HCl Tablets USP, 100 mg, with NDC 75826-114-10.
Check your medication bottle for lot number 1142404 and an expiration date of 02/27/2027 to see if your product is affected.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Phenazopyridine HCl Tablets USP, 100 mg (100-count bottle)

Variants: 100 mg, Tablet, 100-count

Lot Numbers:

1142404 (Exp 02/27/2027)

NDC:

75826-114-10

Rx Only. Manufactured by Winder Laboratories, LLC in Winder, GA.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94727

Status: Resolved

Manufacturer: Winder Laboratories, LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 473 cases (5676 Bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 100-count bottles of Phenazopyridine HCl Tablets USP, 100 mg, with NDC 75826-114-10.

Check your medication bottle for lot number 1142404 and an expiration date of 02/27/2027 to see if your product is affected.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.