By: Virgin Islands Free Press News Desk
ST. CROIX — Federal health regulators have issued a nationwide Class II recall for multiple lots and strengths of Levothyroxine Sodium Tablets, a widely prescribed medication used to treat hypothyroidism and thyroid conditions.
According to enforcement reports from the U.S. Food and Drug Administration (FDA), the voluntary recall was initiated by Indianapolis-based Major Pharmaceuticals after routine stability testing revealed that selected lots failed to meet required potency standards.
The affected pills were categorized as “subpotent,” meaning they deliver less active thyroid hormone than specified on the label.
Why Subpotency Matters for Patients
Levothyroxine sodium is a synthetic thyroid hormone that directly replaces or supplements natural hormone levels in the body. Because precise dosing is crucial to maintaining hormonal balance, even small reductions in potency can cause hypothyroidism symptoms to return or worsen.
Patients taking subpotent tablets may unknowingly receive an under-dose, leading to symptoms such as:
- Chronic fatigue or weakness
- Unexplained weight gain
- Increased sensitivity to cold
- Cognitive difficulties or brain fog
- Dry skin and thinning hair
- Muscle pain or joint stiffness
The FDA designated the action as a Class II recall, which indicates that exposure to the product may cause temporary or medically reversible adverse health consequences, though the probability of severe, long-term harm remains remote.
Recalled Lots and Product Details
The recall encompasses 12 distinct product lines spanning seven dosage strengths—25 mcg, 50 mcg, 75 mcg, 88 mcg, 112 mcg, 125 mcg, and 150 mcg. The affected medications were packaged in unit-dose blister cartons (100-tablet cartons containing ten 10-tablet blister packs) and distributed nationwide, with some lots further distributed under Cardinal Health.
Affected Major Pharmaceuticals Lots Include:
- 25 mcg: Lot #N02212 (Exp: July 2026) | NDC: 0904-6949-61
- 50 mcg: Lot #N02200 (Exp: October 2026) | NDC: 0904-6950-61
- 75 mcg: Lots #N02172, #N02288, #N02296 (Exp: July 2026 – Dec 2026) | NDC: 0904-6951-61
- 88 mcg: Lot #N02310 (Exp: January 2027) | NDC: 0904-6952-61
- 112 mcg: Lot #N02203 (Exp: September 2026) | NDC: 0904-6954-61
- 125 mcg: Lot #N02266 (Exp: November 2026) | NDC: 0904-6955-61
- 150 mcg: Lot #N02167 (Exp: July 2026) | NDC: 0904-6956-61
(Note: Not all levothyroxine on the market is affected. The recall is limited strictly to specified lots packaged by Major Pharmaceuticals and distributed through Cardinal Health).
Guidance for USVI Patients and Consumers
Health officials strongly advise patients not to stop taking their thyroid medication abruptly without consulting a medical professional. Halting treatment completely can allow hypothyroidism symptoms to rapidly escalate.
What to do if you take Levothyroxine:
- Check Your Prescription Box or Packaging: Look for the manufacturer (Major Pharmaceuticals or Cardinal Health), the National Drug Code (NDC), and the lot number on your blister pack or box.
- Contact Your Pharmacy: Because retail pharmacy bottles often place generic labels over distributor packaging, call your dispensing pharmacist to verify whether your refill came from an affected batch.
- Speak with Your Doctor: If your medication is subject to the recall, your primary care physician can arrange for an unaffected replacement batch or adjust your dosage if necessary.
- Report Symptoms: Patients who suspect they are experiencing returning hypothyroidism symptoms should alert their physician.
Pharmacies, clinics, and medical facilities across the territory holding affected lots have been instructed to quarantine remaining inventory immediately.
