The FDA has classified a nationwide recall of the thyroid medication levothyroxine as a Class II recall, covering multiple strengths manufactured by Major Pharmaceuticals. The tablets were found to be “subpotent,” meaning they may deliver less active medication than their labeling promises — a particular concern for patients relying on precise thyroid hormone dosing.
Why Was It Recalled?
Major Pharmaceuticals, based in the Dublin/Indianapolis area and distributed through Cardinal Health, initiated the recall on July 13 after routine stability testing turned up out-of-specification assay results. The FDA upgraded it to a Class II recall on July 17 and published the full enforcement report this week. A Class II recall means using the affected product could cause temporary or reversible health effects, though the FDA describes the probability of serious harm as remote.
Which Lots Are Affected?
The recall spans twelve product lines across seven dosage strengths, all packaged in unit-dose blister cartons. Affected lots include:
- 25 mcg — Lot N02212, expires 07/2026
- 50 mcg — Lot N02200, expires 10/2026
- 75 mcg — Lots N02172 (exp. 07/2026), N02296 and N02288 (exp. 12/2026)
- 88 mcg — Lot N02203, expires 09/2026
- 125 mcg — Lot N02266, expires 11/2026
- 150 mcg — Lot N02167, expires 07/2026
Additional strengths (including 112 mcg) were also named in the manufacturer’s initial notice. Because levothyroxine is sold under many manufacturers and labels, patients should confirm the specific product, lot number, and expiration date on their own bottle rather than assuming a strength match means their prescription is affected.
What Should Patients Do?
- Check the pill bottle or blister packaging for “Major Pharmaceuticals” as the manufacturer or distributor.
- Match the lot number and expiration date against the list above.
- Do not stop taking levothyroxine or adjust the dose without talking to a doctor — untreated hypothyroidism carries its own risks.
- Contact the dispensing pharmacy to verify the manufacturer and request a replacement if the lot is affected.
- Watch for returning hypothyroidism symptoms — fatigue, weight gain, cold intolerance — and report them to a physician, who may order thyroid function tests.
| Quick Facts |
| Recall class: Class II (temporary or reversible health risk) |
| Manufacturer: Major Pharmaceuticals, distributed via Cardinal Health |
| Reason: Tablets found “subpotent” during routine stability testing |
| Strengths affected: 25, 50, 75, 88, 112, 125 and 150 mcg |
| Recall initiated: July 13, 2026; classified Class II on July 17, 2026 |
| Patient action: Check lot number, don’t stop medication without medical advice, contact your pharmacy |
Sources: FDA enforcement report, WFTV/Cox Media Group, AOL/Yahoo News, News4JAX.
