Oseltamivir Phosphate for Oral Suspension — Class III drug recall D-0247-2021
Terminated recall by Lupin Pharmaceuticals Inc., reported 2021-02-10, distributed nationwide. Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 m
| Recall number | D-0247-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2021-01-21 |
| Classified | 2021-02-03 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2021-12-16 |
| Distributed | Nationwide (US) |
| Quantity | 46,479 bottles |
| Reason classes | specification failure |
| NDC | 68180-0678, 68180-0678-01 |
| Lot numbers | A906423 |
| Expiration dates | 2021-11-20 |
Product
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01
Reason for recall
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0247-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.