A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10% — Class III drug recall D-0604-2017
Terminated recall by Bayer HealthCare Pharmaceuticals, Inc., reported 2017-03-29, distributed in PR. Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim iss
| Recall number | D-0604-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer HealthCare Pharmaceuticals, Inc., Morristown, NJ, United States |
| Recall initiated | 2017-02-21 |
| Classified | 2017-03-21 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2018-01-03 |
| Distributed | PR |
| Countries outside the US | IS |
| Reason classes | undeclared allergen, labeling |
| Allergens | milk |
| UPC / GTIN / UDI-DI | 00041100811288, 00041100811301, 00041100811325 |
| Lot numbers | CV0068D, CV0068G, CV0068K, CV0068M, CV008N5, CV008N6, CV008N7, CV008N8, CV008N9, CV008NA, CV008NB, CV008NC, CV008ND, CV008NE, CV008NG, CV008NH, CV008NJ, CV00BJA, CV00BJB, CV00BJC, CV00BJD, CV00BJE, CV00BX9, CV00BXA, CV00BXB, CV00D0U, CV00D0V, CV00D7E, CV00D7G, CV00D7H, CV00D7J, CV00DM4, CV00E5R, CV00E5S, CV00E5T, CV00G4U, CV00G69, CV00G6B |
| Expiration dates | 2018-12-31, 2019-01-31, 2019-02-28, 2019-03-31, 2019-04-30, 2019-05-31, 2019-06-30, 2019-07-31, 2019-08-31, 2019-09-30, 2019-10-31 |
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
Reason for recall
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
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-0604-2017. 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.