Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures
Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate sublingual tablets because they failed content uniformity specifications, resulting in tablets that are either superpotent or subpotent.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves significant deviation from specified potency levels.
Plain-English summary
Virtus Pharmaceuticals OPCO II, LLC. is recalling Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottles. The recall involves 94,643 bottles distributed nationwide and in Puerto Rico. The affected lot numbers are 30051601, 30051602, 30051603, and 30051604, with an expiration date of Jan-18. Note that some bottles from lot 30051602 contain the incorrect expiration date of Jan-28.
The recall was initiated because the product failed content uniformity specifications. This failure resulted in tablets that are both superpotent (containing more active ingredient than specified) and subpotent (containing less active ingredient than specified).
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance. The product is prescription-only (Rx only).
The recalled product
- Product
- 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.
- Manufacturer
- VIRTUS PHARMACEUTICALS OPCO II L
- Category
- Drug — Prescription Medication
- Affected units
- 94,643
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 (6)
- Lot #: 30051601
- 30051602*
- 30051603
- 30051604
- Exp Jan-18
- *some bottles contain the incorrect expiration date of Jan-28.
Distribution
Part of a larger recall action
This product is one of 3 recalled by VIRTUS PHARMACEUTICALS OPCO II L under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · VIRTUS PHARMACEUTICALS OPCO II L
See all →- LowVirtus Pharmaceuticals Recalls Extra-Virt Plus DHA Prenatal Softgels
FDA (Drugs) · 2017-01-04
- ModerateVirtus Pharmaceuticals Recalls Virt-Select Prenatal Softgels Due to GMP Deviations
FDA (Drugs) · 2017-01-04
- LowVirt-Advance Prenatal Softgels Recalled Due to API Manufacturer Import Alert
FDA (Drugs) · 2017-01-04
- LowVirtPrex Prenatal Tablets Recalled Due to API Manufacturer Import Alert
FDA (Drugs) · 2017-01-04
- SevereVirtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures
FDA (Drugs) · 2016-12-28
Same hazard · content uniformity
See all →- ModerateLupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
- HighOral contraceptive tablets recalled after failing content uniformity specifications
FDA (Drugs) · 2025-10-15
- HighCefixime Oral Suspension Recalled for Failed Content Uniformity Specifications
FDA (Drugs) · 2024-06-26
- SevereFDA Recalls Phenytoin Oral Suspension Due to Content Uniformity Failure
FDA (Drugs) · 2023-12-27
- ModerateDofetilide Capsules Recalled Due to Out-of-Specification Content Uniformity
FDA (Drugs) · 2023-08-16