Virtus Recalls Hyoscyamine Sulfate Tablets Due to Broken Dessicants
Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate Sublingual Tablets because bottles may contain broken dessicants.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the Low severity criteria for minor or packaging-related issues.
Plain-English summary
Virtus Pharmaceuticals, LLC is recalling Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles. The recall is due to a chemical contamination issue where bottles may contain broken dessicants.
The affected product is identified by Lot # 638J011A and NDC 76439-0309-10. A total of 24,614 bottles were distributed nationwide and in Puerto Rico. The product is prescription-only.
Consumers should check their medication for this specific lot number and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10
- Manufacturer
- Virtus Pharmaceuticals, Llc
- Category
- Drug — Prescription Medication
- Affected units
- 24,614
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 638J011A
Distribution
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