GaviLyteTM — Class II drug recall D-0726-2021
Terminated recall by Novel Laboratories, Inc. d.b.a LUPIN, reported 2021-08-25, distributed nationwide. Failed Stability Specification; Out of specification for Osmolarity
| Recall number | D-0726-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novel Laboratories, Inc. d.b.a LUPIN, Somerset, NJ, United States |
| Recall initiated | 2021-07-29 |
| Classified | 2021-08-13 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2022-11-14 |
| Distributed | Nationwide (US) |
| Quantity | 20,814 bottles |
| Reason classes | specification failure |
| NDC | 43386-0060, 43386-0060-19 |
| Lot numbers | 001133 |
| Expiration dates | 2022-07 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0726-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.