GaviLyte -C — Class II drug recall D-0875-2022
Terminated recall by Lupin Pharmaceuticals Inc., reported 2022-05-25, distributed nationwide. Failed Stability Specification
| Recall number | D-0875-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2022-04-27 |
| Classified | 2022-05-16 |
| Reported by FDA | 2022-05-25 |
| Terminated | 2023-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 26,910 bottles |
| Reason classes | specification failure |
| NDC | 43386-0060, 43386-0060-19 |
| Lot numbers | S001132 |
| Expiration dates | 2022-07-20 |
Product
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Reason for recall
Failed Stability Specification
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-0875-2022. 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.