Llorens Urin D/S Tablets Recall: Subpotent/Superpotent Risk
Llorens Pharmaceutical recalls Urin D/S Tablets due to potential subpotent or superpotent tablets that may not work as intended. This could lead to ineffective treatment. Contact for details.
Lower-risk 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.
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What happened, in plain English
Llorens Pharmaceutical is recalling Urin D/S Tablets that may be too weak or too strong. This could mean the medication doesn't work properly, risking treatment failure. Read more at govinfonow.com/recall/41269-llorens-urin-d-s-tablets-recall-subpotent-superpotent-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41269-llorens-urin-d-s-tablets-recall-subpotent-superpotent-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0081-2018
Cite this page
“Llorens Urin D/S Tablets Recall: Subpotent/Superpotent Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41269-llorens-urin-d-s-tablets-recall-subpotent-superpotent-risk. Based on FDA recall #D-0081-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0081-2018%22&limit=1).
Why it’s dangerous
The FDA found the tablets may be under-dosed (subpotent) or over-dosed (superpotent) compared to the intended strength. This could mean the medication is less effective or more effective than it should be, potentially causing treatment failure or adverse effects.
Who’s affected
People who have the 100-count Urin D/S Tablets with NDC 54859-701-10, lots 22811601 or 22811602, expiring May 2018 or November 2018. Those using the medication for urinary tract infections are most at risk.
How to tell if you have this one
Check for the 100-count bottle labeled 'Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg'. Look for NDC 54859-701-10, lots 22811601 or 22811602, expiring May 2018 or November 2018.
- Brand
Llorens Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Verify the NDC code, lot numbers, and expiration dates to confirm if your tablets are part of the recall.
Where it went and when
Where it was distributed
Distributed in Puerto Rico.
FDA distribution: “Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Puerto Rico.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The product may not work as intended, so it's recommended to check if it's part of the recall and follow the manufacturer's instructions.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0081-2018 (September 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0081-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.