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 |
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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