Quick Facts at a Glance
- Recall Date
- February 26, 2026
- Hazard Level
- HIGH
- Brands
- LEVOTHYROXINE SODIUM, Macleods Pharmaceuticals Limited
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- LEVOTHYROXINE SODIUM, Macleods Pharmaceuticals Limited
- Product type
- Levothyroxine Sodium Tablet
- Model numbers
- Lot 16240062A, exp date 3/2026
- UPC codes
- 33342-393, 33342-394, 33342-395, 33342-396, 33342-397, 33342-398, 33342-399, 33342-400 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 26, 2026
Reported by FDA DRUG
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Subpotent Drug
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact MACLEODS PHARMA USA, INC or your healthcare provider for guidance. Notification method: Letter
About This Product
Levothyroxine is a thyroid hormone replacement used to treat hypothyroidism. The tablets are taken daily under a clinician's direction.
Why This Is Dangerous
Subpotent tablets deliver less than the labeled dose, which may fail to normalize thyroid hormone levels and worsen hypothyroid symptoms.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Patients may experience persistent hypothyroid symptoms despite taking medication.
Practical Guidance
How to identify if yours is affected
- Check the bottle label for Lot 16240062A
- Check the expiry date on the bottle; 3/2026
- Confirm the bottle contains Levothyroxine Sodium Tablets USP 150 mcg
Where to find product info
NDC 33342-401-44, Lot 16240062A, Exp 3/2026 on bottle label
What timeline to expect
Refund or replacement timelines are not specified for this recall; follow company instructions and clinician guidance. FDA page provides updates.
If the manufacturer is unresponsive
- Consult your pharmacist or healthcare provider
- File a report with FDA MedWatch if you have concerns about adverse effects
How to prevent similar issues
- Always check NDC and lot numbers before taking a new lot
- Buy medicines from reputable, verified pharmacies
- Keep medicines in their original packaging with labels intact
Documentation advice
Keep the recall notice, bottle labels, lot numbers, and any medical notes related to thyroid treatment
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Product Details
Levothyroxine Sodium Tablets USP 150 mcg, 1000-tablet bottle. Rx Only. NDC 33342-401-44. Manufactured for Macleods Pharma USA, Inc., Princeton, NJ. Manufactured by Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Gujarat, India. Lot 16240062A. Exp 3/2026. Quantity: 1315 bottles. Distributed nationwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1315 bottles recalled nationwide
- Lot 16240062A; Exp 3/2026
- Rx Only Levothyroxine Sodium Tablets USP 150 mcg
- Manufactured for Macleods Pharma USA, Inc.; distributed in the U.S.
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Safety Guide
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