Alvogen Levothyroxine Tablets Recall: Sub-potent drug risk
Alvogen recalls 112 mcg levothyroxine tablets due to sub-potent drug levels. This may cause inadequate thyroid hormone treatment. Check NDC 47781-654-90 and lot # HE02221 for affected products.
Lower-risk recall
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Contact the company
What happened, in plain English
Alvogen is recalling levothyroxine sodium tablets that may not contain enough active ingredient. This could lead to improper thyroid hormone treatment if used without medical supervision. Read more at govinfonow.com/recall/33966-alvogen-levothyroxine-tablets-recall-sub-potent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33966-alvogen-levothyroxine-tablets-recall-sub-potent-drug-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0353-2023
Cite this page
“Alvogen Levothyroxine Tablets Recall: Sub-potent drug risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33966-alvogen-levothyroxine-tablets-recall-sub-potent-drug-risk. Based on FDA recall #D-0353-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0353-2023%22&limit=1).
Why it’s dangerous
The tablets may have lower than specified levels of active drug. This could result in inadequate thyroid hormone treatment if taken without medical supervision. The risk is not immediate but may affect treatment effectiveness over time.
Who’s affected
People prescribed levothyroxine by a doctor who received these specific tablets. Those with thyroid conditions are most at risk of treatment issues.
How to tell if you have this one
Check for NDC 47781-654-90 and lot number HE02221 on the product label. These tablets were manufactured in Shenandoah, IA and distributed by Alvogen in New Jersey.
- Brand
Alvogen- Category
Drug
What to do — step by step
Check Product Label
Look for NDC 47781-654-90 and lot number HE02221 on the tablet packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0353-2023 (February 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0353-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.