FDA Drug recall D-1044-2016
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II,…
- FDA Drug
- Class III
- terminated
- Published 2016-06-29
On 2016-06-29 the FDA classified a Class III recall of Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II,… by Virtus Pharmaceuticals, citing chemical Contamination: Bottles may contain broken dessicants.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1044-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-05-13 |
| Published | 2016-06-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Virtus Pharmaceuticals |
| Distribution | US |
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
Chemical Contamination: Bottles may contain broken dessicants
Identifiers
| code_info | Lot #: 638J011A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1044-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.