Use cautionDrug recall · FDA · Published January 21, 2021
Lupin Recalls Oseltamivir Phosphate Oral Suspension Due to Impurity Issues
Lupin Pharmaceuticals recalls 46,479 bottles of Oseltamivir Phosphate Oral Suspension due to out-of-specification impurity levels. Check your lot number.
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Take action
Contact the company
📍Recalling firmLupin Pharmaceuticals Inc.Harborplace Tower, 111 S Calvert St Fl 21st · Baltimore, MD 21202-6174
✎ GovInfoNow plain-language explainer
Lupin Pharmaceuticals Inc. is recalling Oseltamivir Phosphate for Oral Suspension because it failed impurity and degradation specifications. Specifically, test results showed that Impurity C exceeded acceptable limits at the 9-month stability time point. The recall affects 46,479 bottles distributed nationwide. Read more at govinfonow.com/recall/36548-lupin-recalls-oseltamivir-phosphate-oral-suspension-due-to-impurity-issues.
“Lupin Recalls Oseltamivir Phosphate Oral Suspension Due to Impurity Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36548-lupin-recalls-oseltamivir-phosphate-oral-suspension-due-to-impurity-issues. Based on FDA recall #D-0247-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0247-2021%22&limit=1).
Lupin Pharmaceuticals Inc. recalled Oseltamivir Phosphate for Oral Suspension on Jan. 21, 2021, due to failed impurity specifications, the FDA said. The voluntary Class III recall affects 46,479 bottles distributed nationwide.
How to tell if you have it
Brand: Lupin
Product: Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL
NDC: 68180-678-01
Lot #: A906423
Expiration date: Nov 2021
The hazard
The recall was issued because out-of-specification test results were observed for Impurity C at the nine-month long-term stability time point. The product failed impurities and degradation specifications.
Context
GovInfoNow's records show Lupin Pharmaceuticals Inc. has had 90 other recalls on record since Jan. 31, 2013. Recent brand recalls include a Clobetasol Cream recall on Aug. 3, 2026, for failed content uniformity and a Glucagon Emergency Kit recall on June 23, 2026, due to CGMP deviation risks. Other recent recalls of similar products include a Temozolomide 5mg Capsules recall by Rising Pharma on March 3, 2026, due to impurity issues and a Clindamycin Phosphate Topical Solution recall by SUN PHARMACEUTICAL on Nov. 26, 2025, for impurities risk.
How to tell if you have this one
Look for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, in 60 mL bottles manufactured by Lupin Limited. Check the label for NDC 68180-678-01 and Lot # A906423 with an expiration date of November 2021.
Brand
Lupin
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Bottle
Verify if your bottle matches NDC 68180-678-01 and Lot # A906423 with an expiration date of November 2021.
Contact Your Pharmacist
Speak with your healthcare provider or pharmacist to determine if you should replace the medication or continue using it, as no specific remedy is listed in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
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 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
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-0247-2021 (January 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0247-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.