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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97820

14 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 10, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
CA BOTANA International, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

14 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 14

Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02

D-0183-2026
Recall number
D-0183-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
1167 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot Code D54596, exp 1/31/2028

Distribution pattern

CA, CO, FL, PR, WA

drug · product 2 of 14

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

D-0184-2026
Recall number
D-0184-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
1401 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot Code D54757, exp 3/31/2028

Distribution pattern

CA, CO, FL, PR, WA

drug · product 3 of 14

Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05

D-0185-2026
Recall number
D-0185-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
555 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot Code D54361, exp 8/31/2027

Distribution pattern

CA, CO, FL, PR, WA

drug · product 4 of 14

Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05

D-0186-2026
Recall number
D-0186-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
470 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot Code D54066, exp 5/31/2027

Distribution pattern

CA, CO, FL, PR, WA

drug · product 5 of 14

Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02

D-0187-2026
Recall number
D-0187-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
874 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot D53950, exp 5/31/2027

Distribution pattern

CA, CO, FL, PR, WA

drug · product 6 of 14

Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02

D-0188-2026
Recall number
D-0188-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
810 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot D53081, exp 7/31/2026

Distribution pattern

CA, CO, FL, PR, WA

drug · product 7 of 14

Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02

D-0189-2026
Recall number
D-0189-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
805 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot D54597, exp 1/31/2028

Distribution pattern

CA, CO, FL, PR, WA

drug · product 8 of 14

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1

D-0190-2026
Recall number
D-0190-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
1617 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot D53371, exp 10/31/2026

Distribution pattern

CA, CO, FL, PR, WA

drug · product 9 of 14

Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5

D-0191-2026
Recall number
D-0191-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
1492 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot D54098, exp 3/31/2027

Distribution pattern

CA, CO, FL, PR, WA

drug · product 10 of 14

Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6

D-0192-2026
Recall number
D-0192-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
2090 tubes

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot D53797, exp 04/30/27

Distribution pattern

CA, CO, FL, PR, WA

drug · product 11 of 14

Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0

D-0193-2026
Recall number
D-0193-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
3295 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot D53682, exp 3/31/2027

Distribution pattern

CA, CO, FL, PR, WA

drug · product 12 of 14

Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8

D-0194-2026
Recall number
D-0194-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot D53681, exp 03/31/2027

Distribution pattern

CA, CO, FL, PR, WA

drug · product 13 of 14

CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17

D-0195-2026
Recall number
D-0195-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
4890 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot D54447, exp 11/30/2027

Distribution pattern

CA, CO, FL, PR, WA

drug · product 14 of 14

Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8

D-0196-2026
Recall number
D-0196-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Quantity
4890 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot D54947, exp 4/30/2028

Distribution pattern

CA, CO, FL, PR, WA