Virtus Hyoscyamine Tablets Recall: Inconsistent Dosage Risk
Virtus recalls 0.125 mg orally disintegrating hyoscyamine tablets due to inconsistent potency. Rx-only bottles with specific NDC and lot number are affected. Consumers should contact Virtus for details.
Recall notice
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Contact the company
What happened, in plain English
Virtus is recalling 100-count bottles of 0.125 mg hyoscyamine sulfate orally disintegrating tablets that may have inconsistent dosing. This could mean some tablets are too strong or too weak, which is dangerous for people taking this medication. Read more at govinfonow.com/recall/42457-virtus-hyoscyamine-tablets-recall-inconsistent-dosage-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42457-virtus-hyoscyamine-tablets-recall-inconsistent-dosage-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0213-2017
Cite this page
“Virtus Hyoscyamine Tablets Recall: Inconsistent Dosage Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42457-virtus-hyoscyamine-tablets-recall-inconsistent-dosage-risk. Based on FDA recall #D-0213-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0213-2017%22&limit=1).
Why it’s dangerous
The tablets may have inconsistent potency due to failed content uniformity tests. This means some tablets could be significantly stronger or weaker than the labeled dose, which can lead to unsafe medication effects.
Who’s affected
People with a prescription for this medication who own the recalled bottles. Those with specific NDC 76439-307-10 and lot number 30011601 are most at risk.
How to tell if you have this one
Check for the NDC number 76439-307-10 and lot number 30011601 on the bottle. The product is a prescription-only 0.125 mg orally disintegrating tablet.
- Brand
Virtus- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0212-2017 | Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.; Lot #: 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28. | 94,643 bottles |
| D-0213-2017 | Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.; Lot #: 30011601, Exp 01/18 | 10,572 bottles |
| D-0214-2017 | Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.; Lot #: 30031601, 30031602, Exp 01/18 | 24,444 bottles |
What to do — step by step
Check Product Details
Look for the NDC 76439-307-10 and lot number 30011601 on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and 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 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- 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 recall states the tablets may have inconsistent potency, but no specific safety advice is given. Consult Virtus for details.
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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-0213-2017 (September 2, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0213-2017 to see it in context.
- Plain-language summary written by qwen3:4b 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.