FDA Drug recall D-0065-2021
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, D…
- FDA Drug
- Class III
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class III recall of 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, D… by Aurobindo Pharma Usa, citing labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0065-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-10-22 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | NJ |
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
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Identifiers
| ndc | 79395-003-92 |
|---|---|
| code_info | Lot # BO1020080AA3, EXP 7/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2024-12-25 · Aurobindo Pharma Usa - Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, D…
FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa - Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Di…
FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa
All Aurobindo Pharma Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0065-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.