FDA recall record · openFDA
Accord Healthcare, Inc.
89 FDA recalls on record (2023–2025) — 89 drug. 16 still ongoing.
0
Class I (most serious)
87
Class II
2
Class III
16
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
CGMP Deviations: recalling drug products following an FDA inspection. 67
Subpotent Drug: Assay below the approved specification 7
Subpotent 4
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) l 3
Presence of Particulate Matter: Particulate matter identified as fiber. 2
Recalls
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R Class II 2025-04-10 Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I Class II 2025-06-20 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc Class II 2025-06-20 Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc. Class II 2025-06-20 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra Class II 2025-04-10 Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Class II 2025-06-20 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Class II 2025-06-20 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I Class II 2025-06-20 Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Ra Class II 2025-04-10 Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare Class II 2025-09-16 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R Class II 2025-04-10 Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, In Class II 2025-06-20 Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I Class II 2024-11-08 Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Ac Class II 2024-10-01 Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-44 Class II 2024-10-10 Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-44 Class II 2024-10-10 Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440 Class II 2024-10-10 Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27 Class II 2023-02-07 Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Class II 2023-02-07 BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, Class II 2023-02-07 Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b Class II 2023-02-07 Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Class II 2023-01-12 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 Class II 2023-02-07 Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 277 Class II 2023-02-07 rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Class II 2023-02-07 BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) Class II 2023-02-07 Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1, Class II 2023-02-07 Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC Class II 2023-02-07 Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured fo Class II 2023-02-07 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 Class II 2023-02-07 Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27 Class II 2023-07-03 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 Class II 2023-02-07 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 Class II 2023-02-07 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 Class II 2023-02-07 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 Class II 2023-02-07 Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Class II 2023-02-07 Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-c Class II 2023-02-07 Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC Class II 2023-02-07 Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets Class II 2023-02-07 Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-cou Class II 2023-02-07 Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,0 Class II 2023-02-07 Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Class II 2023-02-07 rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Ma Class II 2023-02-07 BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, Class II 2023-02-07 rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manu Class II 2023-02-07 rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Man Class II 2023-02-07 BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham Class II 2023-02-07 Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufa Class II 2023-02-07 Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Man Class II 2023-02-07 rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Man Class II 2023-02-07 Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-c Class II 2023-02-07 Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: A Class II 2023-07-03 Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healt Class II 2023-02-07 Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pha Class II 2023-02-07 Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) Class II 2023-02-07 Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Class II 2023-02-07 Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-co Class II 2023-02-07 Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-c Class II 2023-02-07 Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,00 Class II 2023-02-07 Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-c Class II 2023-02-07 Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-co Class II 2023-02-07 Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-c Class II 2023-02-07 Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,0 Class II 2023-02-07 Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100- Class II 2023-02-07 Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured fo Class II 2023-02-07 Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets Class II 2023-02-07 Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) Class II 2023-02-07 Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1 Class II 2023-02-07 BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, Class II 2023-02-07 Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100 Class II 2023-02-07 Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27 Class II 2023-02-07 Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC Class II 2023-02-07 Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham Class II 2023-02-07 Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcar Class II 2023-02-07 Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-co Class II 2023-02-07 Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-coun Class II 2023-02-07 Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-co Class II 2023-02-07 Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare Class II 2023-02-07 Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle Class II 2023-02-07 rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manu Class II 2023-02-07 Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-cou Class II 2023-02-07 Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-co Class II 2023-02-07 Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-co Class II 2023-02-07 rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 M Class II 2023-02-07 Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-cou Class II 2023-02-07 Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b Class II 2023-02-07 Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27 Class II 2023-02-07 Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Class III 2024-06-18 Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutan Class III 2023-03-29
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.