CLASS II ONGOING Drug recall · Reported 29 Jul 2026 · FDA Enforcement Report
Levothyroxine Sodium Tablets, USP, 50 mcg recalled
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg) dose blisters per, distributed nationwide in the US. The recall was initiated on 13 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0708-2026
- FDA event ID
- 99399
- Recalling firm
- Major Pharmaceuticals, Dublin, OH
- Brand
- Levothyroxine Sodium
- Manufacturer
- Cardinal Health 107, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jul 2026
- FDA classified
- 17 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 13 Jul 2026 | Recall initiated by company | |
| 17 Jul 2026 | Classified by FDA | +4 days |
| 29 Jul 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Bag lot #: N02200A, N02200B, Exp. Date 10/2026; Blister lot #: N02200, Exp. Date 10/2026
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 99399This product is part of a recall event; the main page for the event is Levothyroxine Sodium Tablets, USP, 75 mcg recalled.
More recalls from Major Pharmaceuticals
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 25 mcg recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
Other Levothyroxine recalls
All 114| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |