CLASS II ONGOING Drug recall · Reported 3 Dec 2025 · FDA Enforcement Report

Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF recalled

CA Botana International is recalling Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21% per tube, distributed in California, Colorado, Florida, Puerto Rico, Washington. The recall was initiated on 10 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code D54757, exp 3/31/2028
Quantity recalled1401 tubes

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-0184-2026
FDA event ID
97820
Recalling firm
CA Botana International, San Diego, CA
Classification
Class II
Status
Ongoing
Recall initiated
10 Oct 2025
FDA classified
26 Nov 2025
Reported
3 Dec 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter

Timeline

10 Oct 2025Recall initiated by company
26 Nov 2025Classified by FDA+47 days
3 Dec 2025Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations

Product as listed by the FDA

Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17

Where it was distributed

CA, CO, FL, PR, WA

CaliforniaColoradoFloridaPuerto RicoWashington

Questions about this recall

Why was it recalled?

CGMP Deviations

Which lots are affected?

Lot Code D54757, exp 3/31/2028

Where was it sold?

CA, CO, FL, PR, WA

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

Other products in this recall event

13 other products · FDA event 97820

This product is part of a recall event; the main page for the event is Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIKarina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IIElixir by Coco March Tinted Mineral Sunscreen SPF recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IISugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IIDoctor D. Schwab Controlling Cream recalled by CA BOTANA InternationalCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IIDoctor D. Schwab Controlling Balm with Tea Tree Oil recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IIDoctor D. Schwab Shimmery Sun Lotion Sunscreen SPF recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IIDoctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21% per tube recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IIClearstem You Are Sunshine Spf 50, Zinc Oxide recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IIDoctor D. Schwab Clinical Weh Natural Pain Relief Gel recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IISea Enzyme Ultra Umbrella Sunscreen SPF recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IIElixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IIGabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net per tube recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states
CLASS IIDr. Bump Natural Pain Relief Gel, Menthol recalledCA Botana InternationalManufacturing (CGMP) Deviations5 states

More recalls from CA Botana International

All 14