May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New C
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (
Hazard: CGMP Deviations
May 21, 2025DrugsFDA
Empower Clinic Services, LLC dba Empower Pharmacy recalls Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Phar
Hazard: Lack of Assurance of Sterility
May 21, 2025DrugsFDA
L'Oreal USA recalls La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication
Hazard: cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
May 21, 2025DrugsFDA
L'Oreal USA recalls La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cl
Hazard: cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
May 21, 2025DrugsFDA
L'Oreal USA recalls La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication
Hazard: Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
May 14, 2025DrugsFDA
BSO LLC recalls TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office
Hazard: Presence of Particulate Matter: Glass particles were found in pellet vials.
May 14, 2025DrugsFDA
BSO LLC recalls TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for R
Hazard: Presence of Particulate Matter: Glass particles were found in pellet vials.
May 14, 2025DrugsFDA
BSO LLC recalls TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not
Hazard: Presence of Particulate Matter: Glass particles were found in pellet vials.
May 14, 2025DrugsFDA
BSO LLC recalls TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for R
Hazard: Presence of Particulate Matter: Glass particles were found in pellet vials.
May 14, 2025DrugsFDA
BSO LLC recalls TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for R
Hazard: Presence of Particulate Matter: Glass particles were found in pellet vials.
May 14, 2025DrugsFDA
RemedyRePack Inc. recalls Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 157
Hazard: CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
May 14, 2025DrugsFDA
Siddha Flower Essences, LLC. recalls temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030
Hazard: CGMP Deviations
May 14, 2025DrugsFDA
Apollo Care, LLC recalls FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural
Hazard: Lack of Assurance of Sterility
May 14, 2025DrugsFDA
BRS Analytical Services, LLC recalls Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bot
Hazard: cGMP deviations and lack of assurance of sterility.
May 14, 2025DrugsFDA
BRS Analytical Services, LLC recalls Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant
Hazard: cGMP deviations and lack of assurance of sterility.
May 14, 2025DrugsFDA
BRS Analytical Services, LLC recalls Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Ey
Hazard: cGMP deviations and lack of assurance of sterility.
May 14, 2025DrugsFDA
BRS Analytical Services, LLC recalls Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soot
Hazard: cGMP deviations and lack of assurance of sterility.
May 14, 2025DrugsFDA
BRS Analytical Services, LLC recalls Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drop
Hazard: cGMP deviations and lack of assurance of sterility.
May 14, 2025DrugsFDA
FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura
Hazard: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
May 14, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt.
Hazard: Presence of Particulate Matter
May 7, 2025DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, M
Hazard: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
May 7, 2025DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for:
Hazard: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
May 7, 2025DrugsFDA
American Regent, Inc. recalls niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc
Hazard: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
May 7, 2025DrugsFDA
American Regent, Inc. recalls niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc
Hazard: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
May 7, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra
Hazard: Subpotent
May 7, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R
Hazard: Subpotent
May 7, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra
Hazard: Subpotent