Class I · High risk
Thyroid Tablets
Superpotent Drug
Levothyroxine Sodium Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of a foreign substance: black hair found embedded in tablet.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
33342-0398-44
Compare with the code on your package — it is the most precise check available.
Drug: Levothyroxine Category: Thyroid Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Levothyroxine Sodium NDC 33342-0398 |
112 ug/1 | Tablet Oral |
Macleods Pharmaceuticals Limited | Rx |
- Recalling firm
- Macleods Pharmaceuticals Ltd
- NDC code
- 33342-398-44
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0470-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Levothyroxine recalls
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Class II · Moderate risk
Levothyroxine Sodium Tablets
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Class II · Moderate risk
Levothyroxine Sodium Tablets
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Class II · Moderate risk
Levothyroxine Sodium Tablets
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Class II · Moderate risk
Levothyroxine Sodium Tablets
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Other recalls by Macleods Pharmaceuticals Ltd
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Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Class III · Low risk
Famciclovir Tablets
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Class II · Moderate risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications
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