Accord Healthcare, Inc. Provisional
FDA Flags (103)
Class II RecallSep 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-cou
Classification: Class II
Class II RecallSep 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, I
Classification: Class II
Class II RecallSep 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
Classification: Class II
Class II RecallSep 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
Classification: Class II
Class II RecallSep 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
Classification: Class II
Class II RecallSep 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc
Classification: Class II
Class II RecallSep 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
Classification: Class II
Class II RecallSep 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
Classification: Class II
Class II RecallSep 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-c
Classification: Class II
Class II RecallSep 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-coun
Classification: Class II
Class II RecallSep 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
Classification: Class II
Class II RecallSep 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,
Classification: Class II
Class II RecallJul 2026
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, In
Classification: Class II
Class II RecallOct 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare
Classification: Class II
Class II RecallJul 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I
Classification: Class II
Class II RecallJul 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc
Classification: Class II
Class II RecallJul 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc.
Classification: Class II
Class II RecallJul 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare,
Classification: Class II
Class II RecallJul 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare,
Classification: Class II
Class II RecallJul 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I
Classification: Class II
Class II RecallJul 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, In
Classification: Class II
Class II RecallMay 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R
Classification: Class II
Class II RecallMay 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra
Classification: Class II
Class II RecallMay 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra
Classification: Class II
Class II RecallMay 2025
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R
Classification: Class II
Class II RecallDec 2024
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I
Classification: Class II
Class II RecallNov 2024
ACCORD HEALTHCARE, INC.
Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-44
Classification: Class II
Class II RecallNov 2024
ACCORD HEALTHCARE, INC.
Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-44
Classification: Class II
Class II RecallNov 2024
ACCORD HEALTHCARE, INC.
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440
Classification: Class II
Class II RecallOct 2024
ACCORD HEALTHCARE, INC.
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Ac
Classification: Class II
Class III RecallJul 2024
Accord Healthcare, Inc.
Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord
Classification: Class III
Class II RecallJul 2023
Accord Healthcare, Inc.
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27
Classification: Class II
Class II RecallJul 2023
Accord Healthcare, Inc.
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: A
Classification: Class II
Class III RecallApr 2023
Accord Healthcare, Inc.
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutan
Classification: Class III
Class II RecallMar 2023
Accord Healthcare, Inc.
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,00
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 277
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b)
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured fo
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-co
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-c
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-c
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-c
Classification: Class II
Class II RecallMar 2023
Accord Healthcare, Inc.
Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000
Classification: Class II