Hyoscyamine Sulfate Sublingual Tablets — Class III drug recall D-1044-2016
Terminated recall by Virtus Pharmaceuticals, Llc, reported 2016-06-29, distributed nationwide. Chemical Contamination: Bottles may contain broken dessicants
| Recall number | D-1044-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Virtus Pharmaceuticals, Llc, Tampa, FL, United States |
| Recall initiated | 2016-05-13 |
| Classified | 2016-06-20 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2018-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 24,614 bottles |
| Reason classes | chemical contamination |
| NDC | 76439-0309-10 |
| Lot numbers | 638J011A |
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
Reason for recall
Chemical Contamination: Bottles may contain broken dessicants
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-1044-2016. 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.