Lupin Recalls GaviLyte-C Due to Failed Stability Specs
Lupin recalls GaviLyte-C PEG-3350 oral solution due to failed stability specifications and out-of-specification osmolarity. Check your lot number.
Use caution until it’s fixed
Failed Stability Specification; Out of specification for Osmolarity
Contact the company
What happened, in plain English
Lupin Pharmaceuticals is recalling GaviLyte-C PEG-3350 with Electrolytes for Oral Solution because the product failed stability specifications and was found to be out of specification for osmolarity. The recall affects 20,814 bottles distributed nationwide. No specific remedy or consumer action steps are currently listed in the record. Read more at govinfonow.com/recall/36018-lupin-recalls-gavilyte-c-due-to-failed-stability-specs.
Source Summary by GovInfoNow · govinfonow.com/recall/36018-lupin-recalls-gavilyte-c-due-to-failed-stability-specs · Updated October 10, 2026 · FDA enforcement record: FDA #D-0726-2021
Cite this page
“Lupin Recalls GaviLyte-C Due to Failed Stability Specs.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/36018-lupin-recalls-gavilyte-c-due-to-failed-stability-specs. Based on FDA recall #D-0726-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0726-2021%22&limit=1).
Why it’s dangerous
The product failed stability specifications and was out of specification for osmolarity. This means the chemical balance of the solution may be incorrect, potentially affecting its effectiveness or safety during use, although specific injury mechanisms are not detailed in the record.
Who’s affected
Consumers who purchased GaviLyte-C PEG-3350 oral solution with flavor packs between distribution dates prior to July 29, 2021. Individuals relying on this specific bowel preparation for medical procedures are most at risk of receiving a product that does not meet quality standards.
How to tell if you have this one
Check your bottle for NDC 43386-060-19 and Lot number S001133. The product is GaviLyte-C PEG-3350 (240g) with Electrolytes for Oral Solution, USP, with a Flavor Pack. It was manufactured by Novel Laboratories, Inc. for Lupin Pharmaceuticals, Inc.
- Brand
Lupin- Category
Drug
What to do — step by step
Check Your Product Details
Verify if your bottle has NDC 43386-060-19 and Lot S001133 with an expiration date of 7/2022.
Contact Lupin Pharmaceuticals
Since the remedy field is null, contact Lupin directly for instructions on what to do with the recalled bottles.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for this recall?
The National Drug Code (NDC) for the recalled product is 43386-060-19.
How many bottles are affected by this recall?
Approximately 20,814 bottles are included in this recall.
Where was this product sold?
The product was distributed nationwide across the United States.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0726-2021 (July 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0726-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.