June 11, 2025DrugsFDA
Amerisource Health Services LLC recalls Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed
Hazard: cGMP deviations
June 4, 2025DrugsFDA
EnShiShiXiangNiShangMaoYouXianGongSi recalls ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance,
Hazard: Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
June 4, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Ph
Hazard: OOS results reported for the Dissolution (by UV) test.
June 4, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured f
Hazard: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
June 4, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured
Hazard: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
June 4, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only,
Hazard: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
June 4, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05),
Hazard: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
June 4, 2025DrugsFDA
Alembic Pharmaceuticals Limited recalls Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., B
Hazard: Failed Impurities/Degradation Specifications
May 28, 2025DrugsFDA
KVK Tech, Inc. recalls Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Ma
Hazard: cGMP deviations
May 28, 2025DrugsFDA
KVK Tech, Inc. recalls Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 1894
Hazard: cGMP deviations
May 28, 2025DrugsFDA
AsttraZeneca Pharmaceuticals LP recalls Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation cani
Hazard: Defective delivery system
May 28, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Man
Hazard: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
May 28, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Man
Hazard: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
May 28, 2025DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin
Hazard: Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India,
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in Ind
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in In
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in In
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India,
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in I
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made i
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets,
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g)
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distri
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2
Hazard: CGMP Deviations
May 28, 2025DrugsFDA
KENIL HEALTHCARE PRIVATE LIMITED recalls KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distr
Hazard: CGMP Deviations