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CA BOTANA International, Inc.

CA BOTANA International, Inc. Recalls

All product recalls associated with CA BOTANA International, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

145

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 301–320 of 37661 recalls

Weh Weh Pain Relief Gel (CA Botana) – CGMP deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Mineral Sunscreen SPF 50 (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Gabapentin Capsules (Harvard Drug) – impurity specification failure (2025)

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

Class IIModerate

1...14 151617 18...1884

Page 16 of 1884Next

FDA

Oct 10, 2025

Nationwide

• The Harvard Drug Group LLC

Fesoterodine Tablets (Alembic) – Impurity Levels (2025)

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

Class IIILow

FDAOct 10, 2025Nationwide• Alembic Pharmaceuticals Limited

Giant/Martin's Crunchy Taco Dinner Kit (Teasdale) – undeclared milk (2025)

Undeclared Allergen

Undeclared allergen - milk

Class IHigh

FDAOct 10, 2025AL, CT, FL +8 more• Teasdale Foods, Inc.

Flawless Skin Fluid Moisturizer (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Shimmery Sun Lotion SPF 30 (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Controlling Cream (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

YOU ARE SUNSHINE SPF 50 (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Sugared+Bronzed Sunscreen (CA Botana) – CGMP deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Karina Daily Moisturizer (CA Botana) – CGMP deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Elixir Tinted Sunscreen (CA Botana) – CGMP deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Elixir Mineral Sunscreen SPF 50 (CA BOTANA) – Quality Deviation (2025)

CGMP Deviations

Class IIModerate

FDAOct 10, 2025CA, CO, FL +2 more• CA BOTANA International, Inc.

Myosa for Kids (Myofunctional) – Unauthorized Distribution (2025)

Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.

Moderate

FDAOct 9, 2025Nationwide• Myofunctional Research Company USA

Sucralfate Tablets (Amerisource) – Quality Management (2025)

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Class IIModerate

FDAOct 9, 2025Nationwide• Amerisource Health Services LLC

HeartMate 3 (Thoratec) – Battery Cable Corrosion (2025)

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Moderate

FDAOct 9, 2025Nationwide• Thoratec LLC

Quantum Intersegmental Table (Pivotal Health) – Heat Function Risk (2025)

The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.

Moderate

FDAOct 9, 2025Nationwide• Pivotal Health Solutions, Inc.

Olopatadine Ophthalmic Solution (USV) – Impurity Concern (2025)

Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

Class IIModerate

FDAOct 9, 2025Nationwide• USV Private Limited

ShockPulse Lithotripsy Transducer (Olympus) – startup failure (2025)

The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.

Moderate

FDAOct 8, 2025Nationwide• Olympus Corporation of the Americas

ACUSON Imaging Catheter (Sterilmed) – reprocessing cycles (2025)

Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.

Moderate

FDAOct 8, 2025Nationwide• Sterilmed, Inc.