Records and reported status
Jun 20, 2025 FDA drug enforcement
Subpotent Drug: Assay below the approved specification
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured f... Apr 10, 2025 FDA drug enforcement
Subpotent
Class II Reported ongoing
Distribution: Nationwide US.
Official source for Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Acc... Apr 10, 2025 FDA drug enforcement
Subpotent
Class II Reported ongoing
Distribution: Nationwide US.
Official source for Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Acco... Apr 10, 2025 FDA drug enforcement
Subpotent
Class II Reported ongoing
Distribution: Nationwide US.
Official source for Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Acc... Apr 10, 2025 FDA drug enforcement
Subpotent
Class II Reported ongoing
Distribution: Nationwide US.
Official source for Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Acco... Nov 8, 2024 FDA drug enforcement
Subpotent drug
Class II Reported terminated
Distribution: USA Nationwide
Official source for Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured fo... Oct 10, 2024 FDA drug enforcement
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II Reported terminated
Distribution: Nationwide in the USA and PR
Official source for Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per... Oct 10, 2024 FDA drug enforcement
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II Reported terminated
Distribution: Nationwide in the USA and PR
Official source for Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets pe... Oct 10, 2024 FDA drug enforcement
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II Reported terminated
Distribution: Nationwide in the USA and PR
Official source for Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets pe... Oct 1, 2024 FDA drug enforcement
Failed Impurities/Degradation Specifications.
Class II Reported terminated
Distribution: Nationwide within the United States and PR
Official source for Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Onl... Jun 18, 2024 FDA drug enforcement
Subpotent drug: out of specification results
Class III Reported terminated
Distribution: USA Nationwide
Official source for Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Ma... Jul 3, 2023 FDA drug enforcement
Presence of Particulate Matter: Particulate matter identified as fiber.
Class II Reported terminated
Distribution: Nationwide within the United States
Official source for Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx onl... Jul 3, 2023 FDA drug enforcement
Presence of Particulate Matter: Particulate matter identified as fiber.
Class II Reported terminated
Distribution: Nationwide within the United States
Official source for Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthc... Mar 29, 2023 FDA drug enforcement
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Class III Reported terminated
Distribution: Nationwide in the USA.
Official source for Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For In... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 ... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 1... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 ... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 ... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3... Feb 7, 2023 FDA drug enforcement
CGMP Deviations: recalling drug products following an FDA inspection.
Class II Reported terminated
Distribution: United States including Puerto Rico and Canada
Official source for Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 ...
Reasons in these listed records Subpotent Drug: Assay below the approved specification Subpotent Subpotent drug CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. These examples come from this result page and are not a ranking of every recall reason.
Checking Accord Healthcare, Inc. Is there a recall on accord healthcare, inc. right now? This archive contains 103 records, including 25 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records? Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.