FDA recall, , Moderate risk
MacLeods Levothyroxine Sodium Tablets
Levothyroxine Sodium Tablets are subpotent.
Summary by Recall Canary from the FDA notice
What happened
Macleods Pharma USA, Inc., of Princeton, New Jersey, is recalling Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, because the drug is subpotent. The recall, which began February 26, 2026, covers 1315 bottles distributed nationwide. The product was manufactured by Macleods Pharmaceuticals Ltd., Sarigam, Valsad, INDIA. The FDA added the recall to its Enforcement Report on March 24, 2026, and it was included in the weekly enforcement report on April 1, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Levothyroxine Sodium Tablets USP 150 mcg
- NDC
- 33342-401-44
- Lot code
- 16240062A
Recall details
- Company began the recall
- Sold in
- Nationwide
- Company
- MACLEODS PHARMA USA, INCPrinceton, New Jersey
- Hazard
- Wrong drug strength
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98510
- Recall number
- D-0403-2026
- Quantity recalled
- 1315 bottles
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
