Urin D/S Tablets Methenamine 81 — Class II drug recall D-0081-2018
Terminated recall by Llorens Pharmaceutical Corp., reported 2017-11-22, distributed in PR. Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which c
| Recall number | D-0081-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Llorens Pharmaceutical Corp., Caguas, PR, United States |
| Recall initiated | 2017-09-05 |
| Classified | 2017-11-15 |
| Reported by FDA | 2017-11-22 |
| Terminated | 2019-04-03 |
| Distributed | PR |
| Quantity | 19,232 bottles |
| Reason classes | potency, specification failure |
| NDC | 54859-0701-10 |
| Lot numbers | 05/18, 11/18, 202U1601, 22811601, 22811602 |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0081-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.