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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Phenazopyridine HCl Tablets Recalled Due to Mislabeling with Phenobarbital

Agency Publication Date: June 10, 2024
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Summary

RemedyRepack Inc. is recalling 8 bottles of Phenazopyridine HCl (100 mg) tablets because they were mislabeled and actually contain Phenobarbital (16.2 mg) tablets. Phenazopyridine is typically used to relieve urinary tract pain, while Phenobarbital is a controlled sedative and anti-seizure medication. The recall affects 6-count bottles from lot B2906961-042524 with an expiration date of 02/26/2027.

Risk

Patients taking this mislabeled product will unknowingly ingest Phenobarbital, which can cause unintended sedation, dizziness, or serious central nervous system effects. Additionally, the patient's urinary pain may go untreated, and there is a risk of dangerous drug interactions if the patient is taking other medications.

What You Should Do

  1. The recalled products are 6-count bottles of Phenazopyridine HCl (100 mg) tablets (NDC 70518-0218-00) from lot B2906961-042524 with an expiration date of 02/26/2027. These bottles mistakenly contain Phenobarbital (16.2 mg) tablets.
  2. If you have health concerns or have taken this medication, contact your healthcare provider or pharmacist immediately.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact RemedyRepack Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 (100 mg)
Variants: 100 mg tablets, 6 count bottles, Rx Only
Lot Numbers:
B2906961-042524 (Exp 02/26/2027)
NDC:
70518-0218-00
75826-0114-10

Repackaged by RemedyRepack, Inc. Source product manufactured by Winder Laboratories, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94738
Status: Resolved
Manufacturer: RemedyRepack Inc.
Sold By: Medical facility
Manufactured In: United States
Units Affected: 8 bottles
Distributed To: Pennsylvania

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 ยท 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.