Manufacturer

Accord Healthcare, Inc.

91 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.

51–75 of 91

HighFDA (Drugs)·D-0402-2023·2023-03-08
Phenylephrine Hydrochloride Injection Recalled for Manufacturing Practice Deviations
Accord Healthcare is recalling 5,090 vials of Phenylephrine Hydrochloride Injection due to manufacturing deviations found during an FDA inspection. Affected batches include R2101570, R2101574, and R2101576, distributed in the United States, Puerto Rico, and Canada.
Product
Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0379-2023·2023-03-08
FDA recalls Buspirone Hydrochloride tablets for manufacturing practice deviations
Accord Healthcare is recalling approximately 25,812 bottles of Buspirone Hydrochloride 30mg tablets due to manufacturing practice deviations discovered during an FDA inspection.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0391-2023·2023-03-08
Finasteride Tablets 1 mg Recalled for Manufacturing Quality Deviations
Accord Healthcare recalled 1.4 million bottles of Finasteride 1 mg tablets due to manufacturing quality deviations discovered during FDA inspection. No illnesses have been reported.
Product
Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0376-2023·2023-03-08
Accord Healthcare Recalls Buspirone Hydrochloride Due to Manufacturing Deviations
Accord Healthcare is recalling 24,408 bottles of Buspirone Hydrochloride tablets due to Current Good Manufacturing Practice deviations discovered during an FDA inspection.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0418-2023·2023-03-08
Vigabatrin Oral Solution Recalled for Manufacturing Quality Deviations
Accord Healthcare is recalling 821 cartons of Vigabatrin for Oral Solution due to manufacturing quality deviations found during an FDA inspection. The product was distributed in the United States, Puerto Rico, and Canada.
Product
Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC 16729-52
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0386-2023·2023-03-08
Prescription Doxazosin Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling 44,068 bottles of Doxazosin 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations found during an FDA inspection.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0409-2023·2023-03-08
Simvastatin tablets recalled due to manufacturing process deviations
Accord Healthcare is recalling Simvastatin 10 mg tablets distributed in the U.S., Puerto Rico, and Canada due to manufacturing process deviations discovered during FDA inspection. Patients should contact their pharmacy or healthcare provider.
Product
SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
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
ModerateFDA (Drugs)·D-0398-2023·2023-03-08
Glycopyrrolate injection recalled due to manufacturing practice deviations
Accord Healthcare recalls Glycopyrrolate injection due to manufacturing practice deviations found during FDA inspection. The recall affects 3,164 vials distributed in the US, Puerto Rico, and Canada.
Product
GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
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-0371-2023·2023-03-08
Prescription Drug Recall: Atorvastatin Calcium Tablets for Manufacturing Deviations
Accord Healthcare is recalling Atorvastatin Calcium 10 mg tablets distributed in the United States, Puerto Rico, and Canada following FDA inspection findings of manufacturing deviations.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
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-0430-2023·2023-03-08
Ropinirole Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling 8,184 bottles of Ropinirole 4 mg tablets due to manufacturing practice deviations found during an FDA inspection. The recalled batches were distributed in the United States, Puerto Rico, and Canada.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0420-2023·2023-03-08
Pirfenidone Tablets Recalled Due to Manufacturing Compliance Deviations
Accord Healthcare is recalling Pirfenidone 801 mg tablets due to Current Good Manufacturing Practice deviations identified during an FDA inspection. Affected batches P2202519 and P2202513 were distributed in the United States, Puerto Rico, and Canada.
Product
PIRFENIDONE — PIRFENIDONE (PIRFENIDONE)
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-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-0368-2023·2023-03-08
Aripiprazole 15 mg Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Aripiprazole 15 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during an FDA inspection.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
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-0428-2023·2023-03-08
Ropinirole Tablets Recalled by Accord Healthcare Following FDA Inspection
Accord Healthcare is recalling 25,344 bottles of Ropinirole 2 mg tablets due to manufacturing deviations discovered during an FDA inspection. The recall affects medications distributed in the United States, Puerto Rico, and Canada.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
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-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-0431-2023·2023-03-08
Ropinirole Tablets Recalled Due to Manufacturing Quality Violations
Accord Healthcare is recalling Ropinirole 5mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recall affects 5,112 bottles distributed in the United States, Puerto Rico, and Canada.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
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-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-0401-2023·2023-03-08
Accord Healthcare recalls phenylephrine injection vials due to manufacturing deviations
Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing deviations found during FDA inspection. No illnesses or injuries have been reported.
Product
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton ND
Category
Drug
Distribution
0 states