FDA Drug recall D-0866-2023
Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distr…
- FDA Drug
- Class II
- terminated
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class II recall of Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distr… by Viatris, citing CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are pu….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0866-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-05-25 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Viatris |
| Distribution | n/a |
Product
Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05
Reason
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Identifiers
| code_info | Lot #: 101241A, Exp 10/23 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0866-2023%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.