Recall Enforment Report D-0076-2025

Drug Recall Enforcement Report Class II voluntary initiated by ACCORD HEALTHCARE, INC., originally initiated on 11-08-2024 for the product Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17 The product was recalled due to subpotent drug. The product was distributed nationwide and the recall is currently ongoing.

Field Name	Field Value
Event ID	95747 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0076-2025 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	USA Nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17
Reason For Recall	Subpotent drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	12-11-2024
Recall Initiation Date	11-08-2024 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	ACCORD HEALTHCARE, INC.
Code Info	Lot #: D2300191, Exp 12/31/2025 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17
Status	Ongoing

Recalled Products