FDA recall, , Moderate risk
Pfizer Levoxyl Levothyroxine Sodium Tablets
Levoxyl tablets are subpotent, confirmed by out-of-specification assay during stability testing.
Summary by Recall Canary from the FDA notice
What happened
Pfizer is recalling Levoxyl (levothyroxine sodium tablets, USP) 175 mcg tablets in 100-count and 1000-count bottles because the product is subpotent, confirmed by out-of-specification assay during stability testing. The tablets are distributed by Pfizer Inc., New York, NY 10017 and made in Austria. The recall began on September 29, 2026, and was added to the FDA's Enforcement Report and classified by the FDA on October 16, 2026. The product was distributed nationwide in the US and Puerto Rico.
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 your product and all the details in one listed combination.
An NDC (National Drug Code) is usually printed on the drug's label.
Levoxyl (levothyroxine sodium tablets, USP), tablets
- Strength
- 175 mcg
- NDC
- 60793-859-01
- Lot code
- 24W06
- NDC
- 60793-859-10
- Lot code
- 24W07
Recall details
- Company began the recall
- Sold in
US Nationwide and Puerto Rico
- Company
- Pfizer
- 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
- 99963
- Recall numbers
- D-0051-2027 to D-0052-2027
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
Listed on Recall Canary
