# FDA recall D-0726-2021

> **Novel Laboratories, Inc. d.b.a LUPIN** · Class II · drug recall initiated 2021-07-29.

## Product

GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202  NDC  43386-060-19

## Reason for recall

Failed Stability Specification; Out of specification for Osmolarity

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0726-2021
- **Recalling firm:** Novel Laboratories, Inc. d.b.a LUPIN
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-07-29
- **Report date:** 2021-08-25
- **Termination date:** 2022-11-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerset, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0726-2021

## Citation

> AI Analytics. FDA recall D-0726-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-0726-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*