Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Pack
Summary
The FDA issued a Class II for Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit by Major Pharmaceuticals. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0711-2026
Action Date
2026-07-29
Status
Ongoing
Category
drug
Product Description
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61
Lot/Code Info: Bag lot #: N02167A, Exp. Date 07/2026; Blister lot # N02167, Exp. Date 07/2026
Quantity Affected: N/A
Reason for Recall
Subpotent Drug
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-13
Company
Dublin, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 88 drug-related FDA actions this month.
Major Pharmaceuticals has 12 FDA actions in our database, including 12 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Major Pharmaceuticals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Major Pharmaceuticals have FDA actions?
Major Pharmaceuticals has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0711-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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