Lupin Pharmaceuticals recalls GaviLyte -C oral solution with failed stability specification. This may affect safety and requires checking product details.
“Lupin GaviLyte -C Oral Solution Recall: Failed Stability Specification.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34809-lupin-gavilyte-c-oral-solution-recall-failed-stability-specification. Based on FDA recall #D-0875-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0875-2022%22&limit=1).
The FDA announced on April 27, 2022, that Lupin Pharmaceuticals Inc. voluntarily recalled GaviLyte-C with electrolytes for Oral Solution due to a failed stability specification. The recall affects 26,910 bottles distributed nationwide.
How to tell if you have it
Brand: Lupin Pharmaceuticals
Product: GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack
NDC#: 43386-060-19
Lot #: S001132
Expiration date: July 2022
Quantity: 26,910 bottles
The hazard
The product failed stability specifications. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since January 31, 2013. Recent brand recalls include a Clobetasol Cream recall for failed content uniformity specifications on August 3, 2026, and a Glucagon Emergency Kit recall for CGMP deviation risk on June 23, 2026. Other recent recalls of similar products include a Fluphenazine Elixir recall for failed stability specifications (August 13, 2026), a Phytonadione Injectable Emulsion recall for stability issues (October 31, 2025), and a TERPENICOL Antifungal Solution recall for CGMP stability testing issues (April 8, 2026).
How to tell if you have this one
Check for NDC# 43386-060-19 and lot number S001132 on the product label. The expiration date is July 2022.
Brand
Lupin Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for NDC# 43386-060-19 and lot number S001132 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Product was distributed nationwide, including Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0875-2022 (April 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0875-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.