Manufacturer

Accord Healthcare, Inc.

90 recalls in our database name Accord Healthcare, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–90 of 90

ModerateFDA (Drugs)·D-0413-2023·2023-03-08
Accord Recalls Succinylcholine Chloride Injection Due to Manufacturing Deviations
Accord Healthcare is recalling Succinylcholine Chloride Injection due to manufacturing practice deviations discovered during FDA inspection. The recall affects 48,089 cartons distributed to the U.S., Puerto Rico, and Canada.
Product
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0385-2023·2023-03-08
FDA Recalls Dofetilide Antiarrhythmic Drug for Manufacturing Deviations
Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing compliance deviations identified during FDA inspection. The recall affects approximately 113,003 bottles distributed in the U.S., Puerto Rico, and Canada.
Product
DOFETILIDE — DOFETILIDE (DOFETILIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0414-2023·2023-03-08
Tadalafil tablets recalled due to manufacturing process deviations
Accord Healthcare is recalling Tadalafil 2.5 mg tablets following discovery of manufacturing deviations during an FDA inspection. Approximately 36,773 bottles were distributed in the United States, Puerto Rico, and Canada.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0381-2023·2023-03-08
Daptomycin injection recalled due to manufacturing compliance deviations
Accord Healthcare recalls Daptomycin for Injection in the US, Puerto Rico, and Canada affecting 65,233 vials due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection.
Product
DAPTOMYCIN — DAPTOMYCIN (DAPTOMYCIN)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0387-2023·2023-03-08
Prescription Doxazosin Tablets Recalled for Manufacturing Deviations
Accord Healthcare is recalling Doxazosin 2 mg tablets distributed across the United States, Puerto Rico, and Canada due to manufacturing practice deviations identified during an FDA inspection.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0407-2023·2023-03-08
Rosuvastatin tablets recalled for manufacturing quality control deviations
Accord Healthcare is recalling rosuvastatin 40 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found during an FDA inspection. No illnesses have been reported.
Product
ROSUVASTATIN — ROSUVASTATIN (ROSUVASTATIN)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0382-2023·2023-03-08
Daptomycin Injectable Recalled Due to Manufacturing Deviations
Accord Healthcare is recalling Daptomycin for Injection due to manufacturing practice deviations discovered during FDA inspection. No illnesses or injuries have been reported.
Product
DAPTOMYCIN — DAPTOMYCIN (DAPTOMYCIN)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0383-2023·2023-03-08
Prescription Drug Dofetilide Recalled Due to Manufacturing Compliance Deviations
Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing deviations found during an FDA inspection. The recall involves 37,790 bottles distributed across the United States, Puerto Rico, and Canada.
Product
DOFETILIDE — DOFETILIDE (DOFETILIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0392-2023·2023-03-08
Finasteride 5 mg Tablets Recalled Due to Manufacturing Process Deviations
Accord Healthcare is recalling Finasteride 5 mg tablets due to manufacturing process deviations discovered during FDA inspection. Over 2.7 million bottles distributed in the US, Puerto Rico, and Canada are affected.
Product
FINASTERIDE — FINASTERIDE (FINASTERIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0395-2023·2023-03-08
Accord Healthcare Recalls Glimepiride Tablets Due to CGMP Deviations
Accord Healthcare is recalling Glimepiride 4 mg tablets due to Current Good Manufacturing Practice deviations discovered during an FDA inspection. Approximately 1.16 million bottles across the United States, Puerto Rico, and Canada are affected.
Product
GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0421-2023·2023-03-08
Pravastatin Sodium Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Pravastatin Sodium 10 mg tablets for CGMP deviations found during FDA inspection. About 9,600 bottles were distributed across the United States, Puerto Rico, and Canada. No illnesses reported.
Product
PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0404-2023·2023-03-08
Rosuvastatin Tablets 5mg Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Rosuvastatin tablets 5mg due to manufacturing practice deviations found during an FDA inspection. The recall involves 63,247 bottles distributed across the U.S., Puerto Rico, and Canada.
Product
ROSUVASTATIN — ROSUVASTATIN (ROSUVASTATIN)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0419-2023·2023-03-08
Pirfenidone tablets recalled due to manufacturing process deviations
Accord Healthcare recalls Pirfenidone tablets due to manufacturing practice deviations found during FDA inspection. The recall affects 2,614 cartons distributed in the US, Puerto Rico, and Canada.
Product
PIRFENIDONE — PIRFENIDONE (PIRFENIDONE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0168-2023·2023-02-01
Allopurinol Tablets Recalled for Green Plastic Contamination
Accord Healthcare is recalling Allopurinol 100 mg tablets due to the presence of a small piece of green plastic embedded in some tablets. The plastic poses a potential choking and ingestion hazard.
Product
ALLOPURINOL — ALLOPURINOL (ALLOPURINOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0131-2023·2023-01-25
Daptomycin for Injection Recalled Due to Incorrect Labeling Dosage
Accord Healthcare is recalling Daptomycin for Injection labeled as 350 mg/vial but containing 500 mg/vial vials. The labeling error poses a dosing risk to patients.
Product
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
Category
Drug
Distribution
Distributed nationwide