Drug Recalls

2,051 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 51–100 of 2,051

Drug Recall · August 8, 2026
SHANTOU Qiwei industrial Co., Ltd
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guan
cGMP Deviations
Class II
Drug Recall · August 7, 2026
Golden State Medical Supply Inc.
Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed
CGMP deviations: tablets with black specks.
Class II
Drug Recall · August 7, 2026
Bionpharma Inc.
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
Presence of Foreign Tablets/Capsules
Class III
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60
CGMP Deviations
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-964
CGMP Deviations
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation,
CGMP Deviations
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, I
Subpotent Drug
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 6
CGMP Deviations
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc.,
Subpotent Drug
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp R
Subpotent Drug
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 600
CGMP Deviations
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Dee
CGMP Deviations
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road,
Subpotent Drug
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12.
CGMP Deviations
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made
CGMP Deviations
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL
CGMP Deviations
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC
CGMP Deviations
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA,
CGMP Deviations
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Ro
Subpotent Drug
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC
CGMP Deviations
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Ro
Subpotent Drug
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc
Subpotent Drug
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Ro
Subpotent Drug
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-964
CGMP Deviations
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield
CGMP Deviations
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 6
CGMP Deviations
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Roa
Subpotent Drug
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp R
Subpotent Drug
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc
Subpotent Drug
Class II
Drug Recall · August 6, 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Ro
Subpotent Drug
Class II
Drug Recall · August 6, 2026
Mallinckrodt Hospital Products Inc.
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
Presence of particulate matter: glass and stopper piece
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA,
CGMP Deviations
Class II
Drug Recall · August 6, 2026
Baxter Healthcare Corporation
Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC
CGMP Deviations
Class II
Drug Recall · August 5, 2026
Zydus Pharmaceuticals (USA) Inc
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Class II
Drug Recall · August 5, 2026
OPTIMAL BALANCE PHARMACY
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Ba
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class I
Drug Recall · August 4, 2026
Novartis Pharmaceuticals Corporation
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 007
Failed Dissolution Specifications
Class II
Drug Recall · August 4, 2026
Fresenius Kabi USA, LLC
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-00
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Class I
Drug Recall · August 3, 2026
Shoolin Pharma Chem LLP
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gu
CGMP Deviations:Noted during FDA inspection
Class II
Drug Recall · August 3, 2026
Shoolin Pharma Chem LLP
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mah
CGMP Deviations:Noted during FDA inspection
Class II
Drug Recall · August 3, 2026
Lupin Pharmaceuticals Inc.
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDI
Failed content uniformity specifications.
Class II
Drug Recall · August 3, 2026
Shoolin Pharma Chem LLP
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mah
CGMP Deviations:Noted during FDA inspection
Class II
Drug Recall · August 3, 2026
Shoolin Pharma Chem LLP
TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania,
CGMP Deviations:Noted during FDA inspection
Class II
Drug Recall · August 3, 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthor
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II
Drug Recall · August 3, 2026
Shoolin Pharma Chem LLP
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania
CGMP Deviations:Noted during FDA inspection
Class II
Drug Recall · July 31, 2026
Liebel-Flarsheim Company LLC
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Ralei
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Class I
Drug Recall · July 30, 2026
Heritage Pharmaceuticals Inc
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Class II
Drug Recall · July 29, 2026
Apollo Care, LLC
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-0
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II
Drug Recall · July 29, 2026
Apollo Care, LLC
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II
Drug Recall · July 29, 2026
Apollo Care, LLC
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-0
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II
Drug Recall · July 29, 2026
Shilpa Medicare Limited
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridg
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II