Hyoscyamine Sulfate — Class I drug recall D-0212-2017
Terminated recall by VIRTUS PHARMACEUTICALS OPCO II L, reported 2016-12-28, distributed nationwide. Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
| Recall number | D-0212-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VIRTUS PHARMACEUTICALS OPCO II L, Nashville, TN, United States |
| Recall initiated | 2016-09-02 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2019-09-23 |
| Distributed | Nationwide (US) |
| Quantity | 94,643 bottles |
| Reason classes | potency |
| NDC | 76439-0309-10 |
| Lot numbers | 30051601, 30051603, 30051604, JAN-18 |
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.
Reason for recall
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0212-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.