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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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1,991 recalls · newest first

Food & drug recall · FDAOctober 14, 2025Serious

FARMAKEIO OUTSOURCING LLC — Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01

Prescription medicine · FARMAKEIO OUTSOURCING LLC · 4,929 pellets affected

CGMP Deviations: Potential presence of metal particulate matter

Food & drug recall · FDAOctober 14, 2025Serious

FARMAKEIO OUTSOURCING LLC — Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01

Prescription medicine · FARMAKEIO OUTSOURCING LLC · 21,324 pellets affected

CGMP Deviations: Potential presence of metal particulate matter

Food & drug recall · FDAOctober 14, 2025Serious

FARMAKEIO OUTSOURCING LLC — Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01

Prescription medicine · FARMAKEIO OUTSOURCING LLC · 264,664 pellets affected

CGMP Deviations: Potential presence of metal particulate matter

Food & drug recall · FDAOctober 14, 2025Serious

FARMAKEIO OUTSOURCING LLC — Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01

Prescription medicine · FARMAKEIO OUTSOURCING LLC · 43,424 Pellets affected

CGMP Deviations: Potential presence of metal particulate matter

Food & drug recall · FDAOctober 14, 2025Serious

FARMAKEIO OUTSOURCING LLC — Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01

Prescription medicine · FARMAKEIO OUTSOURCING LLC · 14,329 pellets affected

CGMP Deviations: Potential presence of metal particulate matter

Food & drug recall · FDAOctober 14, 2025Serious

FARMAKEIO OUTSOURCING LLC — Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01

Prescription medicine · FARMAKEIO OUTSOURCING LLC · 36,924 pellets affected

CGMP Deviations: Potential presence of metal particulate matter

Food & drug recall · FDAOctober 14, 2025Serious

FARMAKEIO OUTSOURCING LLC — Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01

Prescription medicine · FARMAKEIO OUTSOURCING LLC · 829 pellets affected

CGMP Deviations: Potential presence of metal particulate matter

Food & drug recall · FDAOctober 14, 2025Serious

FARMAKEIO OUTSOURCING LLC — Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01

Prescription medicine · FARMAKEIO OUTSOURCING LLC · 4,829 pellets affected

CGMP Deviations: Potential presence of metal particulate matter

Food & drug recall · FDAOctober 14, 2025Serious

FARMAKEIO OUTSOURCING LLC — Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01

Prescription medicine · FARMAKEIO OUTSOURCING LLC · 18,124 pellets affected

CGMP Deviations: Potential presence of metal particulate matter

Food & drug recall · FDAOctober 14, 2025Serious

FARMAKEIO OUTSOURCING LLC — Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01

Prescription medicine · FARMAKEIO OUTSOURCING LLC · 103,444 pellets affected

CGMP Deviations: Potential presence of metal particulate matter

Food & drug recall · FDAOctober 13, 2025Serious

Teva Pharmaceuticals USA, Inc — Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only

Prescription medicine · Teva Pharmaceuticals USA, Inc · 4680 cartons affected

Subpotent drug; Clavulanate Potassium component

Food & drug recall · FDAOctober 10, 2025Labelling issue

Endo USA, Inc. — Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only

Prescription medicine · Endo USA, Inc. · 2,035 cartons affected

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

Food & drug recall · FDAOctober 10, 2025Serious

The Harvard Drug Group LLC — Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61

Prescription medicine · The Harvard Drug Group LLC

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

Food & drug recall · FDAOctober 10, 2025Serious

CA BOTANA International, Inc. — CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle

Prescription medicine · CA BOTANA International, Inc. · 4890 bottles affected

CGMP Deviations

Food & drug recall · FDAOctober 10, 2025Serious

The Harvard Drug Group LLC — Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (O

Prescription medicine · The Harvard Drug Group LLC

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

Food & drug recall · FDAOctober 10, 2025Serious

CA BOTANA International, Inc. — 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

Prescription medicine · CA BOTANA International, Inc. · 470 tubes affected

CGMP Deviations

Food & drug recall · FDAOctober 10, 2025Labelling issue

Alembic Pharmaceuticals Limited — Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only

Prescription medicine · Alembic Pharmaceuticals Limited · 4,884 30-count bottles affected

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

Food & drug recall · FDAOctober 10, 2025Labelling issue

Endo USA, Inc. — Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only

Prescription medicine · Endo USA, Inc. · 6,655 cartons affected

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

Food & drug recall · FDAOctober 10, 2025Serious

QuVa Pharma, Inc. — R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuV

Prescription medicine · QuVa Pharma, Inc. · 75,885 syringes affected

Presence of Particulate Matter

Food & drug recall · FDAOctober 10, 2025Serious

Lannett Company Inc. — Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle

Prescription medicine · Lannett Company Inc. · 46,848 90-count bottles affected

Failed Dissolution Specifications