Recall archive
17 recalls · page 1 of 1
Reported Sep 2, 2026Updated Sep 27, 2026
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Subpotent Drug
11 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 8, 2026
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Subpotent Drug
FDA (openFDA drug enforcement)
Reported Oct 15, 2025
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved…
FDA (openFDA drug enforcement)
Reported Jul 23, 2025
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Subpotent Drug: Assay below the approved specification
6 more products in this recall
FDA (openFDA drug enforcement)
Reported May 7, 2025
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Subpotent
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 11, 2024
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Subpotent drug
FDA (openFDA drug enforcement)
Reported Nov 6, 2024
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product details — CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 23, 2024
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specifications.
FDA (openFDA drug enforcement)
Reported Jul 10, 2024
Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Subpotent drug: out of specification results
FDA (openFDA drug enforcement)
Reported Jul 19, 2023
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product details — Presence of Particulate Matter: Particulate matter identified as fiber.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 12, 2023
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Accord Healthcare, Inc.
Matched: Brand · Product details — Sub-potent drug: assay test result below specifications at 9-month timepoint.
FDA (openFDA drug enforcement)
Reported Mar 8, 2023
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product details — CGMP Deviations: recalling drug products following an FDA inspection.
66 more products in this recall
FDA (openFDA drug enforcement)
Reported Feb 1, 2023
Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
FDA (openFDA drug enforcement)
Reported Jan 25, 2023
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
FDA (openFDA drug enforcement)
Reported Feb 17, 2021
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
FDA (openFDA drug enforcement)
Reported Sep 19, 2018
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP…
FDA (openFDA drug enforcement)
Reported Feb 22, 2017
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accord Healthcare, Inc.
Matched: Brand · Product · Product details — Failed tablet/capsule specification: missing break line on the 5mg tablet.
FDA (openFDA drug enforcement)
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