Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: 28161501, Exp 03/17; 28161502, 28161503, Exp 08/17; 28161601, 28161602, Exp 01/18
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Nationwide Laboratories, LLC
Reason for Recall:
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.

Product Codes/Lot Numbers:

Lot #: 28161501, Exp 03/17; 28161502, 28161503, Exp 08/17; 28161601, 28161602, Exp 01/18

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0167-2017

Related Recalls