Bayer Recalls A+D Diaper Rash Cream Due to Labeling Error
Bayer HealthCare Pharmaceuticals is recalling A+D Diaper Rash Cream due to a labeling claim issue regarding undeclared excipients.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a labeling error (undeclared excipients) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bayer HealthCare Pharmaceuticals, Inc. is recalling A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10% due to a labeling claim issue. The recall involves specific lots of the product packaged in 1.5 oz, 3 oz, and 4 oz sizes.
The recall was initiated because of incorrect or undeclared excipients on the product labeling. The affected units were distributed nationwide in the United States, as well as in Puerto Rico and Iceland.
Consumers should check their products for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, consumers should stop using it and contact Bayer HealthCare Pharmaceuticals for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981
- Manufacturer
- Bayer HealthCare Pharmaceuticals, Inc.
- Category
- Drug — Topical OTC
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 (20)
- a) Lot #: CV0068D
- Exp. 12/31/2018
- CV008N6
- Exp. 2/28/2019
- CV008N7
- Exp. 3/31/2019
- CV00BJA
- Exp. 6/30/2019
- CV00D0V and CV00DM4
- Exp.8/31/2019. b) Lot #: CV0068G
- CV008N9
- CV008N8
- Exp. 4/30/2019
- CV00D0U
- Exp. 8/31/2019 and CV00G4U
- Exp.10/31/2019. c) Lot #: CV0068M
- CV0068K
- Exp.1/31/2019
- CV008N5
- Exp. 2/28/2019
Distribution
Distributed in 1 state:
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