Aurobindo Recalls Children's Ibuprofen Suspension Due to Missing Dosing Cups
Aurobindo Pharma USA Inc. is recalling 7,440 bottles of Children's Ibuprofen Oral Suspension because the product is missing dosing cups.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a packaging/labeling defect (missing dosing cups) rather than a contamination or safety hazard.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling 7,440 bottles of Children's Ibuprofen Oral Suspension USP 100 mg per 5 mL, Berry Flavor, 4 fl oz (120 mL). The product is distributed by Chalkboard Health Inc. and was distributed in New Jersey. The specific lot number is BO1020080AA3 with an expiration date of 7/2023.
The recall was initiated because the product is missing dosing cups. This is a labeling issue classified by the FDA as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have this product should stop using it and contact the manufacturer or retailer for a refund or replacement. The product is an over-the-counter pain reliever and fever reducer intended for children.
The recalled product
- Product
- CHILDRENS IBUPROFEN (IBUPROFEN)
- Brand
- CHILDRENS IBUPROFEN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — OTC Pain Reliever
- Affected units
- 7,440
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # BO1020080AA3
- EXP 7/2023
Distribution
Distributed in 1 state:
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