Levothyroxine Recall 2026: Every Lot, Strength and Recall Class
Forbes Health Advisory Board · Naturopathic Doctor
Yes, there are levothyroxine recalls in 2026, and they're all Class II. FDA's Enforcement Report lists recalls of generic levothyroxine sodium tablets from Accord Healthcare, Major Pharmaceuticals, Macleods and Alvogen, every one still marked Ongoing. The largest was reported on September 2, 2026 and covers Accord tablets made by Intas Pharmaceuticals in 12 strengths, recalled as a "Subpotent Drug." No levothyroxine product carries a Class I recall. The Class I thyroid recall in the news, Vitruvias Therapeutics' Thyroid Tablets USP, is desiccated thyroid, which is a different drug.
If you take a thyroid pill every morning, that last point matters most. Some coverage of that recall just says "thyroid medication," and it's easy to read that as levothyroxine. It isn't.
Below is every 2026 levothyroxine lot in FDA's data, copied from FDA's own records, plus what the recall class means and how to find out whether your bottle is involved.
Is There a Levothyroxine Recall in 2026?
FDA's 2026 enforcement data holds five separate levothyroxine recall events. All of them come from FDA's enforcement data, which we pulled through openFDA on October 5, 2026 (FDA last updated that data on September 23, 2026). You can search the same records in FDA's Enforcement Report.
| Firm | Recall numbers | Reported | Class | Reason, in FDA's words |
|---|---|---|---|---|
| Accord Healthcare (made by Intas) | D-0775-2026 to D-0786-2026 | September 2, 2026 | Class II | Subpotent Drug |
| Major Pharmaceuticals | D-0700-2026 to D-0711-2026 | July 29, 2026 | Class II | Subpotent Drug |
| Accord Healthcare (made by Intas) | D-0656-2026 | July 8, 2026 | Class II | Subpotent Drug |
| Macleods Pharma USA | D-0403-2026 | April 1, 2026 | Class II | Subpotent Drug |
| Alvogen (Thyro-Tabs, made by Lloyd) | D-0259-2026 | January 21, 2026 | Class II | Product Mix-Up |
Subpotent means the tablets were found to contain less levothyroxine than the label says. A tablet like that acts like a lower dose than the one your prescriber chose.
One thing FDA's records don't contain is a set of instructions for patients. Each entry lists the product, the lot codes, the class, the reason, and the dates. We also found no FDA press release for these recalls on FDA's recalls page. So advice presented as FDA's instructions for these lots didn't come from these records. What we'd suggest is further down, and it's labelled as ours.
The Accord Healthcare Recall (September 2026)
This is the big one. FDA event 99584 covers Levothyroxine Sodium Tablets, USP, manufactured for Accord Healthcare in Raleigh, North Carolina by Intas Pharmaceuticals in India. Twelve strengths, each with its own recall number, all Class II, all for "Subpotent Drug."
Most of these are 1000-count bottles, which a pharmacy uses to fill many prescriptions. Four strengths also include 90-count bottles, and the 300 mcg recall covers 90-count bottles only. Lots and expiry dates are copied from FDA's record.
| Strength | Recall no. | NDC | Lots (expiry) |
|---|---|---|---|
| 25 mcg | D-0775-2026 | 16729-447-17 (1000) | D2401927, D2401833 (08/31/2026); D2402551, D2402552 (11/30/2026); D2500220 (12/31/2026); D2500223 (01/31/2027) |
| 50 mcg | D-0776-2026 | 16729-448-17 (1000) | D2401834, D2401982 (08/31/2026); D2402584, D2402585, D2402586, D2402588, D2402587, D2402589 (11/30/2026) |
| 75 mcg | D-0777-2026 | 16729-449-17 (1000) | D2402016, D2402017 (08/31/2026) |
| 88 mcg | D-0778-2026 | 16729-450-17 (1000) | D2401813, D2401814 (08/31/2026); D2500200, D2500219 (12/31/2026) |
| 100 mcg | D-0779-2026 | 16729-451-15 (90); 16729-451-17 (1000) | 90-count: D2402186 (09/30/2026). 1000-count: D2402019 (08/31/2026); D2402094 (09/30/2026); D2500022, D2500023, D2500021 (12/31/2026) |
| 112 mcg | D-0780-2026 | 16729-452-17 (1000) | D2402443, D2402444, D2402445 (10/31/2026) |
| 125 mcg | D-0781-2026 | 16729-453-17 (1000) | D2401983 (08/31/2026); D2402640, D2402641 (11/30/2026); D2500224 (01/31/2027) |
| 137 mcg | D-0782-2026 | 16729-454-15 (90); 16729-454-17 (1000) | 90-count: D2402125, D2402126, D2402127 (09/30/2026). 1000-count: D2402523, D2402524 (11/30/2026) |
| 150 mcg | D-0783-2026 | 16729-455-17 (1000) | D2402195, D2402196, D2402197 (09/30/2026) |
| 175 mcg | D-0784-2026 | 16729-456-15 (90); 16729-456-17 (1000) | 90-count: D2402642 (11/30/2026). 1000-count: D2401832 (08/31/2026); D2402525, D2402527, D2402526, D2402644, D2402643 (11/30/2026) |
| 200 mcg | D-0785-2026 | 16729-457-15 (90); 16729-457-17 (1000) | 90-count: D2402430, D2402431 (10/31/2026). 1000-count: D2402432 (10/31/2026); D2500180 (12/31/2026) |
| 300 mcg | D-0786-2026 | 16729-458-15 (90) | D2402337 (10/31/2026) |
Accord had a smaller recall two months earlier. D-0656-2026, reported July 8, 2026, covers its 300 mcg tablets in 90-tablet bottles (NDC 16729-458-15), lot D2401522, with an expiry of 06/2026. Also Class II, also "Subpotent Drug."
The Major Pharmaceuticals Recall (July 2026)
Major's recall is FDA event 99399. These are unit-dose blisters, where each tablet is sealed in its own pocket. All 12 recall numbers are Class II, "Subpotent Drug," reported July 29, 2026.
Seven cover cartons of 100 tablets (10 x 10 blisters) packaged and distributed by Major in Indianapolis:
| Strength as FDA prints it | Recall no. | NDC | Lots (expiry) |
|---|---|---|---|
| 25 mcg (0.025 mg) | D-0700-2026 | 0904-6949-61 | N02212 (07/2026) |
| 50 mcg (0.050 mg) | D-0701-2026 | 0904-6950-61 | N02200 (10/2026) |
| 75 mcg (0.075 mg) | D-0702-2026 | 0904-6951-61 | N02172 (07/2026); N02296, N02288 (12/2026) |
| 88 mcg (0.088 mg) | D-0703-2026 | 0904-6952-61 | N02310 (01/2027) |
| 112 mcg (0.0112 mg) | D-0704-2026 | 0904-6954-61 | N02203 (09/2026) |
| 125 mcg (0.0125 mg) | D-0705-2026 | 0904-6955-61 | N02266 (11/2026) |
| 150 mcg (0.0150 mg) | D-0706-2026 | 0904-6956-61 | N02167 (07/2026) |
The other five cover cartons of 10 unit-dose blisters packaged by Major and distributed by Cardinal Health in Dublin, Ohio:
| Strength as FDA prints it | Recall no. | NDCs as FDA prints them | Lots (expiry) |
|---|---|---|---|
| 25 mcg (0.025 mg) | D-0707-2026 | Carton 55154-3558-0; blister 0904-6949-61 | Bag lots N02212A, N02212B; blister lot N02212 (all 07/2026) |
| 50 mcg (0.050 mg) | D-0708-2026 | Bag 55154-3559-0; blister 0904-6950-61 | Bag lots N02200A, N02200B; blister lot N02200 (all 10/2026) |
| 75 mcg (0.075 mg) | D-0709-2026 | Bag 55154-3560-0; blister 0904-6951-61 | Bag lots N02172A, N02172B (07/2026), N02288A, N02288B (12/2026); blister lots N02172 (07/2026), N02288 (12/2026) |
| 125 mcg (0.0125 mg) | D-0710-2026 | Bag 55154-3562-0; blister 0904-6951-61 | Bag lots N02266A, N02266B; blister lot N02266 (all 11/2026) |
| 150 mcg (0.0150 mg) | D-0711-2026 | Bag 55154-3563-0; blister 0904-6956-61 | Bag lot N02167A; blister lot N02167 (both 07/2026) |
Two oddities, and we've left both exactly as FDA wrote them. The milligram figures for 112, 125 and 150 mcg are printed as 0.0112, 0.0125 and 0.0150 mg, which don't match the microgram strengths (112 mcg is 0.112 mg). And the Cardinal 125 mcg record (D-0710-2026) lists blister NDC 0904-6951-61, the same NDC FDA gives for the 75 mcg blisters. Those look like typos in the record. If either one affects you, the lot number is the better thing to match on.
The Smaller 2026 Levothyroxine Recalls
Macleods, D-0403-2026. Levothyroxine Sodium Tablets USP 150 mcg, 1000-tablet bottle, NDC 33342-401-44, lot 16240062A, expiry 3/2026. Reported April 1, 2026. Class II, "Subpotent Drug."
Alvogen Thyro-Tabs, D-0259-2026. Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150 mcg, 1000 tablets, NDC 47781-662-10, manufactured by Lloyd, Inc. and distributed by Alvogen. Lot MHA21825, expiry December 31, 2027. Reported January 21, 2026. Class II. This one isn't about potency. FDA's reason reads: "Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets."
That's the only 2026 levothyroxine lot in this list with an expiry date still more than a year away.
The Class I Thyroid Recall Is Desiccated Thyroid
On September 23, 2026, FDA's Enforcement Report added recall D-0866-2026: Thyroid Tablets, USP, 1/2 Grain (30 mg), 100 tablets, distributed by Vitruvias Therapeutics of Auburn, Alabama, NDC 69680-166-00. One lot, 504950, expiry 09/30/2026. FDA dates the start of the recall to August 21, 2026. The reason is "Superpotent Drug," meaning more hormone than the label states, and it is Class I.
Thyroid Tablets USP is desiccated thyroid, made from dried pig thyroid gland. The label lists 19 mcg of levothyroxine (T4) and 4.5 mcg of liothyronine (T3) per tablet, which is why it turns up in searches for levothyroxine. Those are the hormones naturally present in the gland extract. The product is a different drug from levothyroxine sodium, the synthetic T4 sold as generic levothyroxine and under brand names like Synthroid.
So if your prescription says levothyroxine, this Class I recall isn't about your medication. If you take a desiccated thyroid product, it may be, and the one lot to look for is 504950 from Vitruvias.
FDA's data has one more desiccated thyroid record from 2026: D-0294-2026, a Class II "Subpotent Drug" recall of bulk Thyroid, USP powder from Specialty Process Labs (lot H22254-1XV, expiry 01/31/2027). It's a raw ingredient labelled "For Manufacturing, Processing or Repackaging Use Only," so it isn't sold to patients directly. If you take a compounded desiccated thyroid, your compounding pharmacy can tell you whether it used this lot.
We found no recall of liothyronine on its own (Cytomel or generic T3) in FDA's data for 2025 or 2026.
What Class I, Class II and Class III Mean
FDA sorts recalls by how much harm the product could do. Its definitions, in short:
- Class I: a reasonable probability that using the product will cause serious adverse health consequences or death.
- Class II: use may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
- Class III: use is not likely to cause adverse health consequences.
Every levothyroxine recall in FDA's data for 2025 and 2026 is Class II or Class III. Class II is still a real defect. FDA judged the likely harm to be temporary or reversible.
What a Weaker or Stronger Tablet Can Feel Like
A subpotent tablet gives you less thyroid hormone than you were prescribed, which can let the symptoms of an underactive thyroid creep back. The National Institute of Diabetes and Digestive and Kidney Diseases lists tiredness, weight gain, trouble tolerating cold and dry skin among them. These come on slowly, which is part of what makes them easy to blame on a bad month.
Too much thyroid hormone runs the other way. The levothyroxine label lists a fast or irregular heartbeat, tremors, heat intolerance, trouble sleeping and weight loss among the signs of taking more than you need. That's the risk with a superpotent product like the Vitruvias lot.
Neither list proves anything about your bottle. Plenty of things shift how a thyroid dose feels, from absorption to taking it too close to calcium or iron. Our post on whether levothyroxine causes weight gain covers the absorption side in detail, and our post on thyroid and weight gain covers what an underactive thyroid itself does to weight.
How to Check Whether Your Levothyroxine Is Recalled
FDA's records don't include patient instructions, so this is our advice, not FDA's.
- Don't stop or change your dose on your own. A recalled lot gets replaced, and your prescriber should be part of any change.
- Call the pharmacy that filled your prescription. They can tell you whose tablets are in your bottle and check them against the recalled NDCs and lots.
- Have your bottle in hand: drug name, strength, and fill date.
- Match on lot numbers. The company name alone doesn't tell you, because only the listed lots are recalled.
- If a lot matches, ask the pharmacy about a replacement, and tell your prescriber, especially if you've noticed a change since that refill.
One more thing about the word Ongoing. It's FDA's status for the recall itself. It doesn't tell you the stock is still out there, and several lots above are already past their printed expiry dates.
Older Levothyroxine Recalls (2025)
FDA's data also holds levothyroxine recalls reported in 2025. Most of those lots have now expired, but they come up often enough in searches to list here.
- Accord Healthcare: subpotent recalls reported May 7, 2025 (D-0394 to D-0397-2025), July 23, 2025 (D-0518 to D-0524-2025) and October 15, 2025 (D-0006-2026, which carries a 2026 number because FDA numbers recalls by fiscal year), across 25, 50, 88, 100, 112, 150 and 175 mcg. All Class II.
- Pfizer Levoxyl 50 mcg, D-0575-2025, lot 24C11 (expiry 2/28/2026), reported August 20, 2025. Class II, "Subpotent drug."
- Mylan 125 and 150 mcg unit-dose blisters, D-0290 and D-0291-2025, reported March 26, 2025. Class II, "Super-Potent Drug."
- Macleods 112 mcg, D-0470-2025, lot MLF2401A, reported June 18, 2025. Class III, for a black hair found embedded in a tablet.
- Lupin 75 mcg, D-0167-2025, lot LA01276, reported January 8, 2025. Class II, for an out-of-specification impurity result. This is the only record on this page FDA lists as Terminated.
When a Recall Is a Good Reason to Recheck Your Labs
If you were on a recalled lot, or you just felt off after a refill and want to know, bloodwork answers the question better than guessing. A TSH alone tells you what your brain is signalling. It doesn't show how much T4 you're actually carrying, or how much of it is becoming T3, the active form.
Every new patient here gets an 80+ biomarker panel (our post on advanced bloodwork explains why the full panel matters), and the thyroid portion includes TSH, Free T3, Free T4, Total T4, T-Uptake, Reverse T3, TPO antibodies and thyroglobulin antibodies. When we retest, we compare against your own earlier numbers, which is exactly what you want after a possible dose change you didn't choose. Our thyroid and adrenal care uses all of the standard tools, T4, T3 and desiccated thyroid included, and we make that choice together with you.
Frequently Asked Questions
Is there a Class I levothyroxine recall in 2026?
No. Every levothyroxine recall in FDA's enforcement data for 2025 and 2026 is Class II or Class III. The 2026 Class I thyroid recall (D-0866-2026, Vitruvias Therapeutics, lot 504950) is for Thyroid Tablets USP, a desiccated thyroid product.
Is Synthroid being recalled?
Not in FDA's enforcement data. A search covering January 2025 through FDA's September 23, 2026 update returned no Synthroid recall, and none for Unithroid, Euthyrox, Tirosint or Cytomel either. The brand-name levothyroxine in that data is Pfizer's Levoxyl, one 50 mcg lot reported in August 2025.
Which levothyroxine manufacturers have recalls in 2026?
Accord Healthcare (tablets made by Intas), Major Pharmaceuticals (unit-dose blisters, some distributed by Cardinal Health), Macleods, and Alvogen for its Thyro-Tabs product made by Lloyd. All Class II.
Is Lupin levothyroxine recalled?
Not in 2026. Lupin's one recall in this data is D-0167-2025, a 75 mcg lot (LA01276) reported January 8, 2025 for an impurity result, and FDA lists it as Terminated.
Should I stop taking my levothyroxine because of the recall?
No, not on your own. Call your pharmacy to check your lot, and talk to your prescriber before changing anything. If your lot is recalled, the fix is a replacement supply.
A recall is a good moment to find out where your thyroid actually stands. Start Feeling Like Yourself Again with a free discovery call.
Med Matrix is a functional medicine clinic in South Portland, Maine, serving patients across Greater Portland and southern New Hampshire.