August 19, 2026DrugsFDA
Liebel-Flarsheim Company LLC recalls Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial,
Hazard: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
August 19, 2026DrugsFDA
Victory Medical Center Pharmacy recalls Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%,
Hazard: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
August 19, 2026DrugsFDA
Buy-Herbal recalls Kian Pee Wan Capsules, 30-count bottles
Hazard: Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
August 19, 2026DrugsFDA
Heritage Pharmaceuticals Inc recalls CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceut
Hazard: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
August 19, 2026DrugsFDA
Prestige Brands Holdings recalls CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarr
Hazard: Lack of assurance of sterility. The recall is due to potential contamination
August 19, 2026DrugsFDA
Shoolin Pharma Chem LLP recalls SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LL
Hazard: CGMP Deviations:Noted during FDA inspection
August 19, 2026DrugsFDA
Shoolin Pharma Chem LLP recalls TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/S
Hazard: CGMP Deviations:Noted during FDA inspection
August 19, 2026DrugsFDA
Shoolin Pharma Chem LLP recalls TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Blo
Hazard: CGMP Deviations:Noted during FDA inspection
August 19, 2026DrugsFDA
Shoolin Pharma Chem LLP recalls TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block
Hazard: CGMP Deviations:Noted during FDA inspection
August 19, 2026DrugsFDA
Shoolin Pharma Chem LLP recalls SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LL
Hazard: CGMP Deviations:Noted during FDA inspection
August 19, 2026DrugsFDA
Apollo Care, LLC recalls SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Onl
Hazard: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
August 19, 2026DrugsFDA
Apollo Care, LLC recalls SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Onl
Hazard: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
August 19, 2026DrugsFDA
Apollo Care, LLC recalls SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection
Hazard: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
August 19, 2026DrugsFDA
Apollo Care, LLC recalls SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only
Hazard: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
August 19, 2026DrugsFDA
Apollo Care, LLC recalls SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injectio
Hazard: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
August 19, 2026DrugsFDA
Apollo Care, LLC recalls SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801
Hazard: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
August 19, 2026DrugsFDA
Apollo Care, LLC recalls SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 M
Hazard: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
August 19, 2026DrugsFDA
Apollo Care, LLC recalls SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801
Hazard: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
August 19, 2026DrugsFDA
Apollo Care, LLC recalls SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3
Hazard: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
August 19, 2026DrugsFDA
Apollo Care, LLC recalls SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3
Hazard: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
August 19, 2026DrugsFDA
Apollo Care, LLC recalls SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801
Hazard: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
August 19, 2026DrugsFDA
Novartis Pharmaceuticals Corporation recalls Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 2783
Hazard: Failed Dissolution Specifications
August 12, 2026DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda,
Hazard: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
August 12, 2026DrugsFDA
Sunny Pharmtech Inc. recalls Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceut
Hazard: Presence of Particulate Matter; identified as stainless steel
August 12, 2026DrugsFDA
Sunny Pharmtech Inc. recalls Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceut
Hazard: Presence of Particulate Matter; identified as stainless steel
August 12, 2026DrugsFDA
Central Admixture Pharmacy Services Inc recalls Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag,
Hazard: Incorrect Product Formulation
August 12, 2026DrugsFDA
Aurobindo Pharma USA Inc recalls Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 P
Hazard: shortfill; reports of empty capsules.
August 5, 2026DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured b
Hazard: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
August 5, 2026DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by
Hazard: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
August 5, 2026DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured
Hazard: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability