CLASS III Drug recall · Reported 29 Mar 2017 · FDA Enforcement Report
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide recalled
Bayer HealthCare Pharmaceuticals is recalling A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, distributed in Puerto Rico. The recall was initiated on 21 Feb 2017 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-0604-2017
- FDA event ID
- 76585
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Morristown, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Feb 2017
- FDA classified
- 21 Mar 2017
- Reported
- 29 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Creams, Ointments & Gels
Timeline
| 21 Feb 2017 | Recall initiated by company | |
| 21 Mar 2017 | Classified by FDA | +28 days |
| 29 Mar 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Product as listed by the FDA
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
Where it was distributed
US Nationwid, Puerto Rico, and Iceland
Questions about this recall
Why was it recalled?
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Which lots are affected?
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, Exp. 12/31/2018; CV008N9, Exp. 3/31/2019; CV008N8, Exp. 4/30/2019; CV00D0U, Exp. 8/31/2019 and CV00G4U, Exp.10/31/2019. c) Lot #: CV0068M, Exp. 12/31/2018; CV0068K, Exp.1/31/2019; CV008N5, Exp. 2/28/2019; CV008NC and CV008NE, Exp. 3/31/2019; CV008ND, CV008NB and CV008NA, Exp.4/30/2019; CV008NH, CV008NG and CV008NJ, Exp. 05/31/2019; CV00BJC, Exp.6/30/2019; CV00BJB, CV00BJE, CV00BJD, CV00BXB, CV00BXA and CV00BX9, Exp.7/31/2019; CV00D7H, CV00D7G, CV00D7E and CV00D7J, Exp. 8/31/2019; CV00E5T, CV00E5S and CV00E5R, Exp. 9/30/19; CV00G69 and CV00G6B, Exp.10/31/2019.
Where was it sold?
US Nationwid, Puerto Rico, and Iceland
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.
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