The FDA has issued a nationwide Class II recall of multiple levothyroxine sodium tablets distributed by Major Pharmaceuticals because some lots may be subpotent and less effective than labeled. Affected strengths range from 25 mcg to 150 mcg in both 10‑ and 100‑tablet packages; specific NDCs, lot numbers and expiration dates are listed above. Patients with the listed lots should stop using the affected tablets (but not stop therapy without medical advice), contact their pharmacy for a refund or replacement, and seek care for any concerning symptoms.
Urgent: FDA Recalls Major Pharmaceuticals' Levothyroxine Tablets Nationwide — Check Your Lot Numbers
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The U.S. Food and Drug Administration (FDA) has announced a nationwide Class II recall of multiple lots of levothyroxine sodium tablets distributed by Major Pharmaceuticals. The affected batches may be subpotent, meaning individual tablets could deliver less active ingredient than labeled and therefore be less effective.
Recalled Products and Identifiers
- Levothyroxine Sodium Tablets — 25 mcg (0.025 mg), 100 tablets
NDC: 0904-6949-61
Lot: N02212
Expiration: 07/2026 - Levothyroxine Sodium Tablets — 50 mcg (0.050 mg), 100 tablets
NDC: 0904-6950-61
Lot: N02200
Expiration: 10/2026 - Levothyroxine Sodium Tablets — 75 mcg (0.075 mg), 100 tablets
NDC: 0904-6951-61
Lots: N02172; N02296; N02288
Expirations: 07/2026; 12/2026 - Levothyroxine Sodium Tablets — 88 mcg (0.088 mg), 100 tablets
NDC: 0904-6952-61
Lot: N02310
Expiration: 01/2027 - Levothyroxine Sodium Tablets — 112 mcg (0.112 mg), 100 tablets
NDC: 0904-6954-61
Lot: N02203
Expiration: 09/2026 - Levothyroxine Sodium Tablets — 125 mcg (0.125 mg), 100 tablets
NDC: 0904-6955-61
Lot: N02266
Expiration: 11/2026 - Levothyroxine Sodium Tablets — 150 mcg (0.150 mg), 100 tablets
NDC: 0904-6956-61
Lot: N02167
Expiration: 07/2026 - Levothyroxine Sodium Tablets — 25 mcg (0.025 mg), 10 tablets
NDCs: 55154-3558-0; 0904-6949-61
Lots: N02212A; N02212B; N02212
Expiration: 07/2026 - Levothyroxine Sodium Tablets — 50 mcg (0.050 mg), 10 tablets
NDCs: 55154-3559-0; 0904-6950-61
Lots: N02200A; N02200B; N02200
Expiration: 10/2026 - Levothyroxine Sodium Tablets — 75 mcg (0.075 mg), 10 tablets
NDCs: 55154-3560-0; 0904-6951-61
Lots: N02172A; N02172B; N02288A; N02288B; N02172; N02288
Expirations: 07/2026; 12/2026 - Levothyroxine Sodium Tablets — 125 mcg (0.125 mg), 10 tablets
NDCs: 55154-3562-0; 0904-6955-61
Lots: N02266A; N02266B; N02266
Expiration: 11/2026 - Levothyroxine Sodium Tablets — 150 mcg (0.150 mg), 10 tablets
NDCs: 55154-3563-0; 0904-6956-61
Lots: N02167A; N02167
Expiration: 07/2026
What Patients Should Do
- Check your medication now. Compare the strength, package size, NDC and lot number with the list above.
- If you have any of the affected lots, do not use them and contact your pharmacy for a refund or replacement.
- Do not stop taking levothyroxine abruptly. If you are concerned about your dose or symptoms, contact your prescribing clinician before making changes.
- If you experience symptoms of undertreated hypothyroidism (fatigue, weight gain, cold intolerance, constipation, depression, slowed heart rate) or other health concerns after taking the recalled tablets, seek medical attention promptly.
- For questions about the recall, contact the FDA at 1-888-INFO-FDA (1-888-463-6332).
Recall Details
The recall is classified as Class II, which means the product may cause temporary or medically reversible adverse health consequences. The manufacturer and the FDA describe the affected tablets as potentially "subpotent," indicating some tablets may contain less active ingredient than labeled and therefore provide reduced therapeutic effect.
Source: FDA recall notice; reported by EatingWell. If you are unsure whether your medication is affected, consult your pharmacist or healthcare provider.
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