CLASS III Drug recall · Reported 11 Nov 2020 · FDA Enforcement Report
Fluent Children's Fever + Pain Ibuprofen Oral Suspension recalled
Aurobindo Pharma USA is recalling Fluent Children's Fever + Pain Ibuprofen Oral Suspension USP 100 mg per Pain, distributed in New Jersey. The recall was initiated on 22 Oct 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0065-2021
- FDA event ID
- 86567
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Brand
- Childrens Ibuprofen
- Manufacturer
- Chalkboard Health
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Oct 2020
- FDA classified
- 5 Nov 2020
- Reported
- 11 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 22 Oct 2020 | Recall initiated by company | |
| 5 Nov 2020 | Classified by FDA | +14 days |
| 11 Nov 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Product as listed by the FDA
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
Where it was distributed
NJ
Questions about this recall
Why was it recalled?
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Which lots are affected?
Lot # BO1020080AA3, EXP 7/2023
Where was it sold?
NJ
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aurobindo Pharma USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
Other Ibuprofen recalls
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen | Strides Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled | Direct Rx | Potency & Assay | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 600 mg recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 400 mg recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |