Gavilyte-N — Class II drug recall D-1113-2019
Terminated recall by LUPIN SOMERSET, reported 2019-04-17, distributed nationwide. Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as a
| Recall number | D-1113-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LUPIN SOMERSET, Somerset, NJ, United States |
| Recall initiated | 2019-03-19 |
| Classified | 2019-04-09 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2022-05-23 |
| Distributed | Nationwide (US) |
| Quantity | 76,422 bottles |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00343386050192, 00343386200023, 00343386202027 |
| NDC | 43386-0050, 43386-0050-19 |
| Expiration dates | 2020-11-30, 2020-12-31, 2021-02-28, 2021-03-31, 2021-08-31 |
Product
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD NDC 43386-050-19 UPC 343386050192 a) Lemon Flavor Pack net wt. 2 g UPC 343386200023 b) Orange Flavor Pack net wt. 2 g UPC 343386202027 c) Cherry Flavor Pack net wt. 2 g UPC 3433862034
Reason for recall
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
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-1113-2019. 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.