Lupin Pharmaceuticals Recalls GaviLyte-C Laxative Powder Due to Failed Stability Testing
Lupin Pharmaceuticals is recalling GaviLyte-C bowel-preparation powder nationwide (26,910 bottles) because the product failed stability testing, potentially indicating degraded ingredients or reduced effectiveness. Patients should contact their doctor for a replacement.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is based on failed stability testing, which is a documented manufacturing/quality issue for a prescription medication, but the actual harm is theoretical rather than confirmed.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling GaviLyte-C (Polyethylene Glycol 3350 and electrolytes with flavor pack), an oral powder used for bowel preparation before colonoscopies and other medical procedures. The recall affects 26,910 bottles distributed nationwide, including Puerto Rico. The specific lot involved is Lot #S001132 with an expiration date of July 2022.
The recall was initiated because the product failed to meet required stability specifications. Stability testing ensures that medications maintain their proper composition, potency, and safety characteristics throughout their shelf life. When a product fails these tests, it may indicate that the active ingredients have degraded over time, potentially reducing the medication's effectiveness or creating unknown safety risks.
Patients who have received this medication should not use it and should contact their healthcare provider or pharmacy for a replacement or alternative bowel-preparation option. The FDA has classified this as a Class II recall.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- GAVILYTE - C (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK)
- Brand
- GAVILYTE - C
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Affected units
- 26,910
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # S001132
- exp. date July 2022 NDC # 43386-060-19
Distribution
Related recalls
Same brand · GAVILYTE - C
- ModerateGavilyte-C Oral Solution Recalled for Failed Stability Specification
FDA (Drugs) · 2021-08-25
Same manufacturer · Lupin Pharmaceuticals Inc.
See all →- ModerateLupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
- SevereGlucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- ModerateGanirelix acetate injection recalled after failing an impurity specification
FDA (Drugs) · 2025-12-17
Same hazard · stability failure
See all →- ModerateMylan Recalls Prasugrel Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-09
- LowChiesi Recalls Revcovi Injection Due to Stability Specification Failure
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateZone 2 lidocaine cream recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateVasocaine lidocaine spray recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11