Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg… — Class III drug recall D-0065-2021
Terminated recall by Aurobindo Pharma USA Inc., reported 2020-11-11, distributed in NJ. Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
| Recall number | D-0065-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2020-10-22 |
| Classified | 2020-11-05 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2023-04-04 |
| Distributed | NJ |
| Quantity | 7,440 bottles |
| Reason classes | labeling |
| NDC | 79395-0003, 79395-0003-92 |
| Lot numbers | BO1020080AA3 |
| Expiration dates | 2023-07 |
Product
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92
Reason for recall
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
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-0065-2021. 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.