Lower riskDrug recall · FDA · Published February 26, 2026
Macleods Levothyroxine Tablets Recall: Subpotent Drug Risk
Macleods Pharma recalls 150 mcg levothyroxine tablets due to subpotent drug levels. This may not provide proper thyroid hormone treatment. Consumers should contact pharmacy for guidance.
“Macleods Levothyroxine Tablets Recall: Subpotent Drug Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31469-macleods-levothyroxine-tablets-recall-subpotent-drug-risk. Based on FDA recall #D-0403-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0403-2026%22&limit=1).
The FDA announced on Feb. 26, 2026, that Macleods Pharma USA, Inc. is recalling Levothyroxine Sodium Tablets USP 150 mcg due to a subpotent drug hazard. The firm initiated this voluntary Class II recall affecting 1,315 bottles distributed nationwide.
How to tell if you have it
Brand: Macleods Pharma
Product: Levothyroxine Sodium Tablets USP 150 mcg
Packaging: 1000 Tablets bottle, Rx Only
NDC: 33342-401-44
Lot code: 16240062A
Expiration date: 3/2026
Quantity: 1,315 bottles
The hazard
The recall addresses a subpotent drug hazard in Levothyroxine Sodium Tablets USP 150 mcg. The affected product was manufactured by Macleods Pharmaceuticals Ltd. in Sarigam, Valsad, Gujarat, India, for Macleods Pharma USA, Inc. in Princeton, NJ.
Context
GovInfoNow's records show Macleods Pharma USA, Inc. has 20 other recalls on record since Dec. 24, 2015. Other recent recalls of similar products include a May 7, 2024 recall for foreign substance hazards and a Jan. 5, 2023 recall for embossing mismatch risks. Public reports indicate 99,522 adverse-event reports in the FDA's FAERS database name this product, with 69,293 marked serious and 8,264 listing a death.
How to tell if you have this one
Look for the bottle labeled 'Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets' with NDC 33342-401-44. The lot number 16240062A was manufactured in Princeton, NJ, and expires March 2026.
Brand
Macleods Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Medication Details
Verify the product label matches the recalled item: 150 mcg levothyroxine tablets, 1000 tablets, NDC 33342-401-44, lot 16240062A.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0403-2026 (February 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0403-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.