Why it was recalled
Presence of a foreign substance: black hair found embedded in tablet.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: MLF2401A, Exp 01/31/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0470-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 29, 2025
- FDA report date
- Jun 18, 2025
- Quantity
- 1,344- 1000 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharmaceuticals Ltd
Original FDA data
Every field from FDA enforcement report D-0470-2025, exactly as published.
Show all FDA fields
- City
- Mumbai
- Status
- Ongoing
- Country
- India
- Event ID
- 96979
- Address
- 304 Atlanta Arcade
- Address (line 2)
- Church Road
- Code information
- Lot #: MLF2401A, Exp 01/31/2026
- Report date
- Jun 18, 2025
- Product type
- Drugs
- Recall number
- D-0470-2025
- Classification
- Class III
- Recalling firm
- Macleods Pharmaceuticals Ltd
- Product quantity
- 1,344- 1000 count bottles
- Reason for recall
- Presence of a foreign substance: black hair found embedded in tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 29, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 12, 2025