CLASS II Drug recall · Reported 25 May 2022 · FDA Enforcement Report
GaviLyte -C (Polyethylene Glycol 3350 and electrolytes recalled
Lupin Pharmaceuticals is recalling GaviLyte -C (Polyethylene Glycol 3350 and electrolytes for Oral Solution, USP with flavor, distributed nationwide in the US. The recall was initiated on 27 Apr 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0875-2022
- FDA event ID
- 90094
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Gavilyte - C
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Apr 2022
- FDA classified
- 16 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 27 Apr 2022 | Recall initiated by company | |
| 16 May 2022 | Classified by FDA | +19 days |
| 25 May 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specification
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Where it was distributed
Product was distributed nationwide, including Puerto Rico.
Questions about this recall
Why was it recalled?
Failed Stability Specification
Which lots are affected?
Lot # S001132, exp. date July 2022 NDC # 43386-060-19
Where was it sold?
Product was distributed nationwide, including Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Polyethylene Glycol-3350 recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Miralax (Polyethylene Glycol 3350), Powder for Solution recalledMiralax | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | GaviLyteTM - C PEG-3350 and Electrolytes for Oral Solution recalledGavilyte - C | Novel Laboratories Inc. d.b.a Lupin | Potency & Assay | Nationwide |
| Drug | CLASS II | Gavilyte-N, PEG-3350, Sodium chloride recalled by Lupin SomersetGavilyte-n | Lupin Somerset | Other | Nationwide |
| Drug | CLASS II | Polyethylene Glycol 3350, powder, for solution BRE recalled | Kroger Specialty Pharmacy | Other | 5 states |