Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Urin D/S Tablets Methenamine 81.6 mg Recalled by Llorens Pharmaceutical Corp. Due to Superpotent Drug: Subpotent Drug. FDA analysis found this...

Date: September 5, 2017
Company: Llorens Pharmaceutical Corp.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Llorens Pharmaceutical Corp. directly.

Affected Products

Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, Rx Only, 100-count bottle, Manufactured For: Llorens Pharmaceutical Corp., International Division, Miami, FL 33166. NDC: 54859-701-10

Quantity: 19232 bottles

Why Was This Recalled?

Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.

Where Was This Sold?

Puerto Rico

About Llorens Pharmaceutical Corp.

Llorens Pharmaceutical Corp. has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report