# FDA recall D-0866-2023

> **Viatris Inc** · Class II · drug recall initiated 2023-05-25.

## 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 for recall

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.

## Distribution

Product was distributed to 10 distributors who may have further distribute the product to the retail level.

## Key facts

- **Recall number:** D-0866-2023
- **Recalling firm:** Viatris Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-05-25
- **Report date:** 2023-06-14
- **Termination date:** 2024-04-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Canonsburg, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0866-2023

## Citation

> AI Analytics. FDA recall D-0866-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0866-2023. Source: US FDA. Licensed CC0.

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