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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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2,102 recalls · newest first

Food & drug recall · FDAMay 2, 2025Serious

Empower Clinic Services, LLC dba Empower Pharmacy — Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone

Prescription medicine · Empower Clinic Services, LLC dba Empower… · 8,230 vials affected

Lack of Assurance of Sterility

Food & drug recall · FDAApril 28, 2025Serious

BSO LLC — TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70

Prescription medicine · BSO LLC · 1,974 vials affected

Presence of Particulate Matter: Glass particles were found in pellet vials.

Food & drug recall · FDAApril 28, 2025Serious

BSO LLC — TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01

Prescription medicine · BSO LLC · 1,964 vials affected

Presence of Particulate Matter: Glass particles were found in pellet vials.

Food & drug recall · FDAApril 28, 2025Serious

BSO LLC — TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, N

Prescription medicine · BSO LLC · 355 vials affected

Presence of Particulate Matter: Glass particles were found in pellet vials.

Food & drug recall · FDAApril 28, 2025Serious

BSO LLC — TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70

Prescription medicine · BSO LLC · 1,447 vials affected

Presence of Particulate Matter: Glass particles were found in pellet vials.

Food & drug recall · FDAApril 28, 2025Serious

BSO LLC — TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70

Prescription medicine · BSO LLC · 2,762 vials affected

Presence of Particulate Matter: Glass particles were found in pellet vials.

Food & drug recall · FDAApril 28, 2025Serious

Siddha Flower Essences, LLC. — temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray

Prescription medicine · Siddha Flower Essences, LLC. · N/A affected

CGMP Deviations

Food & drug recall · FDAApril 25, 2025Serious

Mckesson Medical-Surgical Inc. Corporate Office — Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01

Prescription medicine · Mckesson Medical-Surgical Inc. Corporate… · 3 affected

Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified…

Food & drug recall · FDAApril 24, 2025Serious

KENIL HEALTHCARE PRIVATE LIMITED — Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.

Prescription medicine · KENIL HEALTHCARE PRIVATE LIMITED · 9,000 Bottles affected

CGMP Deviations

Food & drug recall · FDAApril 24, 2025Serious

KENIL HEALTHCARE PRIVATE LIMITED — Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube

Prescription medicine · KENIL HEALTHCARE PRIVATE LIMITED · 6,372 Tubes affected

CGMP Deviations

Food & drug recall · FDAApril 24, 2025Serious

KENIL HEALTHCARE PRIVATE LIMITED — Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube

Prescription medicine · KENIL HEALTHCARE PRIVATE LIMITED · 10,000 Tubes affected

CGMP Deviations

Food & drug recall · FDAApril 24, 2025Serious

KENIL HEALTHCARE PRIVATE LIMITED — Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 557

Prescription medicine · KENIL HEALTHCARE PRIVATE LIMITED · 9,984 Tubes affected

CGMP Deviations

Food & drug recall · FDAApril 24, 2025Serious

KENIL HEALTHCARE PRIVATE LIMITED — CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube

Prescription medicine · KENIL HEALTHCARE PRIVATE LIMITED · 10,788 Tubes affected

CGMP Deviations

Food & drug recall · FDAApril 23, 2025Serious

BRS Analytical Services, LLC — Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle

Prescription medicine · BRS Analytical Services, LLC · 1,610 cases (24 cartons per case) affected

cGMP deviations and lack of assurance of sterility.

Food & drug recall · FDAApril 22, 2025Serious

RemedyRePack Inc. — Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02

Prescription medicine · RemedyRePack Inc. · 23 bottles/30 count- 690 capsules affected

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

Food & drug recall · FDAApril 21, 2025Serious

Eugia US LLC — Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only

Prescription medicine · Eugia US LLC

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Food & drug recall · FDAApril 21, 2025Serious

Eugia US LLC — Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only

Prescription medicine · Eugia US LLC · 18,867 bags affected

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Food & drug recall · FDAApril 21, 2025Serious

Mckesson Medical-Surgical Inc. Corporate Office — BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

Prescription medicine · Mckesson Medical-Surgical Inc. Corporate… · 3 Vials affected

CGMP Deviations; potential temperature excursions due to transit delays

Food & drug recall · FDAApril 21, 2025Serious

Mckesson Medical-Surgical Inc. Corporate Office — PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only

Prescription medicine · Mckesson Medical-Surgical Inc. Corporate… · 6 Pre-filled syringes affected

CGMP Deviations; potential temperature excursions due to transit delays

Food & drug recall · FDAApril 21, 2025Serious

Mckesson Medical-Surgical Inc. Corporate Office — EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only

Prescription medicine · Mckesson Medical-Surgical Inc. Corporate… · 2 Pre-filled syringes affected

CGMP Deviations; potential temperature excursions due to transit delays