Tea tree balm recalled over current good manufacturing practice deviations
CA Botana International is recalling 555 tubes of Doctor D. Schwab Controlling Balm with Tea Tree Oil for CGMP deviations.
What this means for you
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: Scored 2 because the record cites CGMP deviations without describing an identified defect or reported harm.
Plain-English summary
Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicylic Acid 0.8%, in 1 fl oz (30 mL) tubes, NDC 35192-016-05, from Doctor D. Schwab, a division of CA Botana of San Diego, California, is being recalled for CGMP deviations.
The recall covers 555 tubes from lot D54361, expiring 31 August 2027. The product was distributed in California, Colorado, Florida, Puerto Rico and Washington. The FDA has classified the recall as Class II.
The enforcement record cites the manufacturing practice deviations without describing a specific defect or health consequence, and reports no injuries.
Anyone holding a tube from lot D54361 should follow the firm's instructions.
The recalled product
- Product
- 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
- Manufacturer
- CA BOTANA International, Inc.
- Category
- Drug — Topical
- Hazard
- Affected units
- 555
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 (2)
- Lot Code D54361
- exp 8/31/2027
Distribution
Part of a larger recall action
This product is one of 14 recalled by CA BOTANA International, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · CA BOTANA International, Inc.
See all →- ModerateSchwab mineral sunscreen recalled over manufacturing practice deviations at Botana
FDA (Drugs) · 2025-12-03
- ModerateMineral sunscreen recalled over current good manufacturing practice deviations
FDA (Drugs) · 2025-12-03
- ModerateTinted mineral sunscreen recalled over manufacturing practice deviations
FDA (Drugs) · 2025-12-03
- ModerateMenthol pain relief gel recalled over manufacturing practice deviations
FDA (Drugs) · 2025-12-03
- ModerateMineral sunscreen recalled over current good manufacturing practice deviations
FDA (Drugs) · 2025-12-03
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- HighShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate USP Recalled for CGMP Deviations Noted During FDA Inspection
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate Recall Due to CGMP Deviations
FDA (Drugs) · 2026-08-19