CLASS III ONGOING Drug recall · Reported 18 Jun 2025 · FDA Enforcement Report
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg) recalled
Macleods Pharmaceuticals is recalling Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), distributed nationwide in the US. The recall was initiated on 29 May 2025 and the FDA has classified it as Class III.
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-0470-2025
- FDA event ID
- 96979
- Recalling firm
- Macleods Pharmaceuticals, Mumbai
- Brand
- Levothyroxine Sodium
- Manufacturer
- Macleods Pharmaceuticals Limited
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 29 May 2025
- FDA classified
- 12 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Thyroid Medication
Timeline
| 29 May 2025 | Recall initiated by company | |
| 12 Jun 2025 | Classified by FDA | +14 days |
| 18 Jun 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of a foreign substance: black hair found embedded in tablet.
Product as listed by the FDA
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of a foreign substance: black hair found embedded in tablet.
Which lots are affected?
Lot #: MLF2401A, Exp 01/31/2026
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Macleods Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS III | Olanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapine | Macleods Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Famciclovir Tablets, USP 500 mg recalled by Macleods PharmaceuticalsFamciclovir | Macleods Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Olanzapine Tablets, USP 2.5 mg recalled by Macleods PharmaceuticalsOlanzapine | Macleods Pharmaceuticals | Potency & Assay | Nationwide |
Other Levothyroxine recalls
All 145| 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 |