Levothyroxine Sodium Tablets, 50 mcg recall — Major Pharmaceuticals (Class II)
Major Pharmaceuticals is recorded by the U.S. Food and Drug Administration (FDA) as recalling Levothyroxine Sodium Tablets, 50 mcg — a Class II recall, initiated 2026-07-13 and posted to the FDA enforcement report on 2026-07-29, under recall number D-0708-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Subpotent Drug”. From the product description, the form is tablets, the strengths given are 50 mcg and 0.050 mg, the package is described as 10 Tablets (10 x 1) unit dose blisters per carton and it is marked Rx only. 2 National Drug Code numbers are printed in the record: 55154-3559-0 and 0904-6950-61. Distribution is recorded as “Nationwide in the USA” — Nationwide (US), with the recalling firm on record in OH, United States. The FDA files it under event ID 99399 together with 11 other recall numbers, all listed and linked below. Within that event this is the strength 50 mcg · 0.050 mg, package 10 Tablets (10 x 1) unit dose blisters per carton and ndc 55154-3559-0 · 0904-6950-61 configuration; the sibling records differ on strength, package and ndc and match on everything else the source states. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.
Regulatory snapshot
| Recall number | D-0708-2026 |
|---|---|
| FDA event ID | 99399 (12 recall numbers) |
| Classification | Class II (intermediate regulatory tier) |
| Status | Ongoing |
| Recalling firm | Major Pharmaceuticals |
| Recall initiated | 2026-07-13 |
| Reported by FDA | 2026-07-29 |
| Report lag | 16 days from initiation to report |
| Distribution | Nationwide in the USA. — Nationwide (US) |
| Firm location on record | OH, United States |
| Product description (source) | 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 |
Reason reported by FDA
Subpotent Drug
2 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.
Product identifiers in this record
8 identifying values matched by exact pattern in the 43-word product description above; each is a literal substring of it.
| Product named | Levothyroxine Sodium Tablets |
|---|---|
| Form | Tablets |
| Strength | 50 mcg · 0.050 mg |
| Package | 10 Tablets (10 x 1) unit dose blisters per carton |
| NDC | Bag: 55154-3559-0 · Blister: 0904-6950-61 |
| Marketing category | Rx only |
| Distributed by | MAJOR PHARMACEUTICALS, Indianapolis |
Which configuration this record is
12 recall numbers share event 99399. They differ on strength, package and ndc and agree on everything else the source states, so those are the values to check a package against.
Shared across all 12 records under this event: form Tablets; product named Levothyroxine Sodium Tablets; fda tier Class II; recalling firm Major Pharmaceuticals; reason text Subpotent Drug; initiated 2026-07-13; reported 2026-07-29.
Event context: 12 recall numbers under event 99399
One enforcement action, 12 recall numbers: the FDA filed 11 further configurations of this action under event 99399. Each keeps its own recall number and dates.
| Recall record | Recall number | FDA tier | Strength / form | NDC | Reported |
|---|---|---|---|---|---|
| Levothyroxine Sodium Tablets, 25 mcg | D-0700-2026 | Class II | 25 mcg · Tablets | 0904-6949-61 | 2026-07-29 |
| Levothyroxine Sodium Tablets, 50 mcg | D-0701-2026 | Class II | 50 mcg · Tablets | 0904-6950-61 | 2026-07-29 |
| Levothyroxine Sodium Tablets, 75 mcg | D-0702-2026 | Class II | 75 mcg · Tablets | 0904-6951-61 | 2026-07-29 |
| Levothyroxine Sodium Tablets, 88 mcg | D-0703-2026 | Class II | 88 mcg · Tablets | 0904-6952-61 | 2026-07-29 |
| Levothyroxine Sodium Tablets, 112 mcg | D-0704-2026 | Class II | 112 mcg · Tablets | 0904-6954-61 | 2026-07-29 |
| Levothyroxine Sodium Tablets, 125 mcg | D-0705-2026 | Class II | 125 mcg · Tablets | 0904-6955-61 | 2026-07-29 |
| Levothyroxine Sodium Tablets, 150 mcg | D-0706-2026 | Class II | 150 mcg · Tablets | 0904-6956-61 | 2026-07-29 |
| Levothyroxine Sodium Tablets, 25 mcg | D-0707-2026 | Class II | 25 mcg · Tablets | 55154-3558-0 | 2026-07-29 |
| Levothyroxine Sodium Tablets, 75 mcg | D-0709-2026 | Class II | 75 mcg · Tablets | 55154-3560-0 | 2026-07-29 |
| Levothyroxine Sodium Tablets, 125 mcg | D-0710-2026 | Class II | 125 mcg · Tablets | 55154-3562-0 | 2026-07-29 |
| Levothyroxine Sodium Tablets, 150 mcg | D-0711-2026 | Class II | 150 mcg · Tablets | 55154-3563-0 | 2026-07-29 |
Other indexed recalls of levothyroxine sodium
13 indexed records name levothyroxine sodium as the recalled substance. Matching is on the product-name prefix of the FDA's own text, so other strengths and packages are included.
| Recall record | Recall number | Recalling firm | Strength / form | Reported |
|---|---|---|---|---|
| Levothyroxine Sodium Tablets, 300 mcg | D-0656-2026 | Accord Healthcare, Inc. | 300 mcg · Tablets | 2026-07-08 |
Reported in the same month (2026-07)
111 enforcement reports carry a report date in 2026-07; these 8 are the Class II ones nearest this record.
| Recall record | Recall number | Recalling firm | FDA tier | Reported |
|---|---|---|---|---|
| Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg | D-0712-2026 | Ascend Laboratories, LLC | Class II | 2026-07-29 |
| Rohto Cooling Eye Drops ALL-IN-ONE, 0.2% | D-0715-2026 | Rohto-mentholatum (vietnam) Co., Ltd. | Class II | 2026-07-29 |
| Rohto Cooling Eye Drops Max Strength, 0.03% | D-0716-2026 | Rohto-mentholatum (vietnam) Co., Ltd. | Class II | 2026-07-29 |
| Rohto Cooling Eye Drops Max Strength, 0.03% | D-0717-2026 | Rohto-mentholatum (vietnam) Co., Ltd. | Class II | 2026-07-29 |
| Rohto Cooling Eye Drops Optic Glow, 0.03% | D-0718-2026 | Rohto-mentholatum (vietnam) Co., Ltd. | Class II | 2026-07-29 |
| Rohto Cooling Eye Drops Digi Eye, 0.35% | D-0719-2026 | Rohto-mentholatum (vietnam) Co., Ltd. | Class II | 2026-07-29 |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%) | D-0720-2026 | Rohto-mentholatum (vietnam) Co., Ltd. | Class II | 2026-07-29 |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%) | D-0721-2026 | Rohto-mentholatum (vietnam) Co., Ltd. | Class II | 2026-07-29 |
Reading this record
Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 99399 returns all 12 of these recall numbers; a search on D-0708-2026 returns only this configuration. Match a package against 55154-3559-0 (Bag) and 0904-6950-61 (Blister) at the FDA source to confirm it is covered.
Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Major Pharmaceuticals (12 indexed records) aggregates this firm across datasets.
Coverage and limits of this record
This page reflects the openFDA enforcement report for D-0708-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.
Source & provenance
- Official source
- https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0708-2026%22
- Source dataset
- openFDA Drug Enforcement API
- Publication date
- 2026-07-29
- Ingested
- 2026-08-22
- Record hash
445edbac62dbcb58
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.