CLASS I Drug recall · Reported 28 Dec 2016 · FDA Enforcement Report
Hyoscyamine Sulfate, USP Tablets recalled by Virtus Pharmaceuticals Opco
Virtus Pharmaceuticals Opco II L is recalling Hyoscyamine Sulfate, USP Tablets, 0, distributed nationwide in the US. The recall was initiated on 2 Sep 2016 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0214-2017
- FDA event ID
- 75146
- Recalling firm
- Virtus Pharmaceuticals Opco II L, Nashville, TN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Sep 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 2 Sep 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +111 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Which lots are affected?
Lot #: 30031601, 30031602, Exp 01/18
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 75146This product is part of a recall event; the main page for the event is Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg recalled | Virtus Pharmaceuticals Opco II L | Potency & Assay | Nationwide | |
| CLASS I | Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg recalled | Virtus Pharmaceuticals Opco II L | Potency & Assay | Nationwide |
More recalls from Virtus Pharmaceuticals Opco II L
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | VirtPrex Prenatal/Postnatal Tablets recalled | Virtus Pharmaceuticals Opco II L | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Virt-Advance Prenatal/Postnatal Softgels recalled | Virtus Pharmaceuticals Opco II L | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Extra-Virt Plus DHA Prenatal/Postnatal Softgel recalled | Virtus Pharmaceuticals Opco II L | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Virt-Select Prenatal/Postnatal Softgels recalled | Virtus Pharmaceuticals Opco II L | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg recalled | Virtus Pharmaceuticals Opco II L | Potency & Assay | Nationwide |
Other Hyoscyamine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hyoscyamine Oral Drops 0.125 mg/mL recalled by Torrent Pharma | Torrent Pharma | Sterility | Nationwide |
| Drug | CLASS I | Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg recalled | Virtus Pharmaceuticals Opco II L | Potency & Assay | Nationwide |
| Drug | CLASS I | Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg recalled | Virtus Pharmaceuticals Opco II L | Potency & Assay | Nationwide |
| Drug | CLASS II | Hyoscyamine Sulfate ODT, Tablet, 0.125 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Hyoscyamine Sulfate ER, Tablet, 0.375 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |