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FDA Drug Recalls

778 recalls, newest first

Class II · Moderate risk Ongoing Oct 14, 2025

Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100…

Reason CGMP Deviations: Potential presence of metal particulate matter

Farmakeio Outsourcing LLC NDC 73693-0381-01 D-0127-2026

Class II · Moderate risk Ongoing Oct 14, 2025

Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100…

Reason CGMP Deviations: Potential presence of metal particulate matter

Farmakeio Outsourcing LLC NDC 73693-0386-01 D-0126-2026

Class II · Moderate risk Ongoing Oct 14, 2025

Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100…

Reason CGMP Deviations: Potential presence of metal particulate matter

Farmakeio Outsourcing LLC NDC 73693-0383-01 D-0125-2026

Class II · Moderate risk Ongoing Oct 14, 2025

Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100…

Reason CGMP Deviations: Potential presence of metal particulate matter

Farmakeio Outsourcing LLC NDC 73693-0387-01 D-0124-2026

Class II · Moderate risk Ongoing Oct 14, 2025

Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100…

Reason CGMP Deviations: Potential presence of metal particulate matter

Farmakeio Outsourcing LLC NDC 73693-0389-01 D-0123-2026

Class II · Moderate risk Ongoing Oct 13, 2025

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only…

Reason Subpotent drug; Clavulanate Potassium component

Teva Pharmaceuticals USA, Inc NDC 0093-2277-7 D-0151-2026

Class II · Moderate risk Ongoing Oct 10, 2025

Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured…

Reason Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

Safecor Health, LLC D-0214-2026

Class II · Moderate risk Ongoing Oct 10, 2025

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…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0196-2026

Class II · Moderate risk Ongoing Oct 10, 2025

CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0195-2026

Class II · Moderate risk Ongoing Oct 10, 2025

Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0194-2026

Class II · Moderate risk Ongoing Oct 10, 2025

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…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0193-2026

Class II · Moderate risk Ongoing Oct 10, 2025

Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0192-2026

Class II · Moderate risk Ongoing Oct 10, 2025

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…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0191-2026

Class II · Moderate risk Ongoing Oct 10, 2025

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0190-2026

Class II · Moderate risk Ongoing Oct 10, 2025

Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0189-2026

Class II · Moderate risk Ongoing Oct 10, 2025

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…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0188-2026

Class II · Moderate risk Ongoing Oct 10, 2025

Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0187-2026

Class II · Moderate risk Ongoing Oct 10, 2025

Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0186-2026

Class II · Moderate risk Ongoing Oct 10, 2025

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…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0185-2026

Class II · Moderate risk Ongoing Oct 10, 2025

Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0184-2026

Class II · Moderate risk Ongoing Oct 10, 2025

Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA…

Reason CGMP Deviations

CA BOTANA International, Inc. D-0183-2026

Class III · Low risk Ongoing Oct 10, 2025

Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals…

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

Alembic Pharmaceuticals Limited NDC 62332-175-30 D-0156-2026

Class III · Low risk Ongoing Oct 10, 2025

Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Endo USA, Inc. NDC 49884-119-91 D-0142-2026

Class III · Low risk Ongoing Oct 10, 2025

Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Endo USA, Inc. NDC 49884-128-91 D-0141-2026

Class III · Low risk Ongoing Oct 10, 2025

Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Endo USA, Inc. NDC 49884-127-91 D-0140-2026