FDA Drug recall D-0214-2017
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC.,…
- FDA Drug
- Class I
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class I recall of Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC.,… by Virtus Pharmaceuticals Opco Ii L, citing failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0214-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-09-02 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Virtus Pharmaceuticals Opco Ii L |
| Distribution | US |
Product
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.
Reason
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Identifiers
| code_info | Lot #: 30031601, 30031602, Exp 01/18 |
|---|
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-0214-2017%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.