Accord Healthcare, Inc.

Complete recall history across all FDA and CPSC categories — 93 total recalls

Accord Healthcare, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (93)

FDA drug safety enforcement actions by Accord Healthcare, Inc.. Showing most recent 50.

Date Product Reason Class
Sep 16, 2025 Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, ... Subpotent: During long term stability testing of Levothyroxine Sodium Tablets... Class II
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx On... Subpotent Drug: Assay below the approved specification Class II
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx O... Subpotent Drug: Assay below the approved specification Class II
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx ... Subpotent Drug: Assay below the approved specification Class II
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx ... Subpotent Drug: Assay below the approved specification Class II
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only... Subpotent Drug: Assay below the approved specification Class II
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Onl... Subpotent Drug: Assay below the approved specification Class II
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx O... Subpotent Drug: Assay below the approved specification Class II
Apr 10, 2025 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, ... Subpotent Class II
Apr 10, 2025 Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, M... Subpotent Class II
Apr 10, 2025 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, M... Subpotent Class II
Apr 10, 2025 Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, ... Subpotent Class II
Nov 8, 2024 Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx O... Subpotent drug Class II
Oct 10, 2024 Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-1... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet... Class II
Oct 10, 2024 Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet... Class II
Oct 10, 2024 Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet... Class II
Oct 1, 2024 Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multip... Failed Impurities/Degradation Specifications. Class II
Jun 18, 2024 Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple do... Subpotent drug: out of specification results Class III
Jul 3, 2023 Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multipl... Presence of Particulate Matter: Particulate matter identified as fiber. Class II
Jul 3, 2023 Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured... Presence of Particulate Matter: Particulate matter identified as fiber. Class II
Mar 29, 2023 Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multipl... Sub-potent drug: assay test result below specifications at 9-month timepoint. Class III
Feb 7, 2023 Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured ... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bott... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC ... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: ... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 1... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC ... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Acc... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-1... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, R... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC ... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 167... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 ... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufa... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactur... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured ... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, ND... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufac... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, ... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle,... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial ... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets N... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC ... CGMP Deviations: recalling drug products following an FDA inspection. Class II
Feb 7, 2023 Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC... CGMP Deviations: recalling drug products following an FDA inspection. Class II

View all 93 drug recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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