CLASS II Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
GaviLyteTM - C PEG-3350 and Electrolytes for Oral Solution recalled
Novel Laboratories Inc. d.b.a Lupin is recalling GaviLyteTM - C PEG-3350 and Electrolytes for Oral Solution, USP with Flavor Pack, distributed nationwide in the US. The recall was initiated on 29 Jul 2021 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-0726-2021
- FDA event ID
- 88390
- Recalling firm
- Novel Laboratories Inc. d.b.a Lupin, Somerset, NJ
- Brand
- Gavilyte - C
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2021
- FDA classified
- 13 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 29 Jul 2021 | Recall initiated by company | |
| 13 Aug 2021 | Classified by FDA | +15 days |
| 25 Aug 2021 | Published in enforcement report | +12 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; Out of specification for Osmolarity
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
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specification; Out of specification for Osmolarity
Which lots are affected?
Lot S001133, exp 7/2022
Where was it sold?
Nationwide
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.
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 | GaviLyte -C (Polyethylene Glycol 3350 and electrolytes recalledGavilyte - C | Lupin Pharmaceuticals | 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 |