Year

2023 Product Recalls

5,218 product recalls issued in 2023 across CPSC, FDA, and USDA datasets.

5,218 recalls
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: ...
Oral Drugs·139,332 affected·Feb 7, 2023
High RiskFDA
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) 500 Tablets NDC ...
Oral Drugs·24,408 affected·Feb 7, 2023
High RiskFDA
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) 1,000 Tablets NDC 1...
Oral Drugs·256,106 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufacture...
Oral Drugs·1,970 affected·Feb 7, 2023
High RiskFDA
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 for: Accord Healthc...
Injectable Drugs·3,164 affected·Feb 7, 2023
High RiskFDA
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-count bottle NDC 16...
Oral Drugs·176,323 affected·Feb 7, 2023
High RiskFDA
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-count bottle, NDC ...
Oral Drugs·539,004 affected·Feb 7, 2023
High RiskFDA
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-count bottle NDC 1...
Oral Drugs·469,944 affected·Feb 7, 2023
High RiskFDA
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-count bottle NDC 1...
Oral Drugs·312,864 affected·Feb 7, 2023
High RiskFDA
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-count tablets ND...
Oral Drugs·1,190,484 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by:...
Oral Drugs·1,440,652 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
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-count bottle NDC ...
Oral Drugs·36,773 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactur...
Oral Drugs·120 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
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 NDC 16729-415-17...
Oral Drugs·31,116 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
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-count bottle NDC 167...
Oral Drugs·44,068 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles ...
Oral Drugs·43,302 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC...
Injectable Drugs·9,888 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: In...
Oral Drugs·25,344 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufac...
Oral Drugs·3,784 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Inta...
Oral Drugs·5,112 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Int...
Oral Drugs·14,928 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufa...
Oral Drugs·23,784 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas ...
Oral Drugs·2,641 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Ac...
Injectable Drugs·48,089 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Int...
Oral Drugs·104,945 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
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-count bottle NDC 1...
Oral Drugs·1,394,208 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durh...
Injectable Drugs·37,691 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-3...
Injectable Drugs·228,760 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose v...
Injectable Drugs·65,233 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcar...
Injectable Drugs·322 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
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-count bottle NDC 16...
Oral Drugs·256,648 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
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-count bottle NDC 1...
Oral Drugs·205,631 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle ND...
Oral Drugs·291,378 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 1...
Oral Drugs·613,553 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
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-count NDC 16729-414...
Oral Drugs·69,122 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-count bottle NDC 1...
Oral Drugs·102,360 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16...
Oral Drugs·241,585 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count bottle, NDC...
Oral Drugs·747,464 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord Healthc...
Injectable Drugs·5,273 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16...
Oral Drugs·992,622 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottl...
Oral Drugs·56,862 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle...
Oral Drugs·63,247 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufac...
Oral Drugs·10,992 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, ND...
Oral Drugs·170,448 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufacture...
Oral Drugs·113,003 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufact...
Oral Drugs·37,790 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufa...
Oral Drugs·821 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, ...
Injectable Drugs·5,090 affected·Feb 7, 2023