Virtus Recalls Hyoscyamine Sulfate Tablets Due to Broken Desiccants
Virtus Pharmaceuticals recalls 24,614 bottles of Hyoscyamine Sulfate Sublingual Tablets (Lot 638J011A) due to chemical contamination from broken desiccants.
Use caution until it’s fixed
Chemical Contamination: Bottles may contain broken dessicants
Contact the company
What happened, in plain English
Virtus Pharmaceuticals is recalling one lot of Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, because the bottles may contain broken desiccants. This presents a risk of chemical contamination in the medication. The recall affects 24,614 bottles distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/42693-virtus-recalls-hyoscyamine-sulfate-tablets-due-to-broken-desiccants.
Source Summary by GovInfoNow · govinfonow.com/recall/42693-virtus-recalls-hyoscyamine-sulfate-tablets-due-to-broken-desiccants · Updated October 9, 2026 · FDA enforcement record: FDA #D-1044-2016
Cite this page
“Virtus Recalls Hyoscyamine Sulfate Tablets Due to Broken Desiccants.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42693-virtus-recalls-hyoscyamine-sulfate-tablets-due-to-broken-desiccants. Based on FDA recall #D-1044-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1044-2016%22&limit=1).
Why it’s dangerous
The desiccants inside the medication bottles may have broken, leading to chemical contamination of the tablets. Ingesting contaminated medication can pose health risks that vary depending on the nature of the chemical exposure.
Who’s affected
Patients who have been prescribed Hyoscyamine Sulfate Sublingual Tablets manufactured by Virtus Pharmaceuticals for the specific lot identified in this recall. Individuals who purchased these 100-count bottles from pharmacies or distributors across the United States and Puerto Rico are potentially affected.
How to tell if you have this one
Check your bottle for the following details: Product name 'Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg', NDC 76439-0309-10, and Lot # 638J011A. The product is packaged in 100-count bottles and manufactured for Virtus Pharmaceuticals OPCO II, LLC in Nashville, TN.
- Brand
Virtus Pharmaceuticals- Category
Drug
What to do — step by step
Check your medication
Verify if your bottle matches the recalled NDC 76439-0309-10 and Lot # 638J011A.
Contact your pharmacist or doctor
Since no specific remedy is listed in the record, consult your healthcare provider for guidance on what to do with the medication.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide & Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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
What is the NDC number for the recalled product?
The National Drug Code (NDC) is 76439-0309-10.
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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-1044-2016 (May 13, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1044-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.