Agency: Food and Drug Administration (FDA) | Date: 20260401 | Units: 1315 bottles | Risk: Class II
This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified April 7, 2026.
Stock photo for illustration — not the actual recalled product. Photo by Etactics Inc on Unsplash
Heads up if you recently got a refill for your thyroid medication! Macleods Pharma USA, Inc. has issued a voluntary product recall in the United States that you need to be aware of. If you're taking Levothyroxine Sodium Tablets, read on to check if your medication is affected.
- Product: Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only
- Company: MACLEODS PHARMA USA, INC.
- Reason: Subpotent Drug
- Units Affected: 1315 bottles
- Remedy: Stop using and contact your doctor
- Lot Number: 16240062A, exp date 3/2026
- Date Announced: April 1, 2026
Is Your Medication Affected by This Recall?
Macleods Pharma USA, Inc. is voluntarily recalling one specific lot of Levothyroxine Sodium Tablets USP 150 mcg. This product is packaged in bottles of 1000 tablets and is available by prescription only. The affected lot is Lot 16240062A with an expiration date of 3/2026. The NDC number is 33342-401-44. Check your bottle immediately to see if it matches this information. This product was distributed nationwide to pharmacies across the U.S., so American shoppers in any state could potentially have received it. Approximately 1315 bottles are included in this product recall in the United States.
Nobody wants to find out their medication isn't working as it should. This recall is due to the tablets being subpotent, meaning they might not contain the correct amount of active ingredient. Taking a subpotent dose of Levothyroxine can lead to symptoms of hypothyroidism not being properly controlled.
Why This Recall Matters
This is classified as a Class II recall, which means that use of or exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. For people taking Levothyroxine to manage hypothyroidism, a subpotent dose could lead to symptoms like fatigue, weight gain, constipation, and other related issues. It’s crucial to ensure you're receiving the correct dosage of your medication to properly manage your condition.
Macleods Pharma USA, Inc. is the manufacturer, with the tablets themselves being made by Macleods Pharmaceuticals Ltd. in India. According to the FDA, the official source for this recall, there are currently no reports of adverse events. It's still really important for U.S. consumers to check their medication and take appropriate action, just in case.
What To Do Right Now
- Check your bottle of Levothyroxine Sodium Tablets USP 150 mcg for the lot number 16240062A and expiration date of 3/2026, printed directly on the bottle label.
- If your medication is from the recalled lot, stop taking it immediately and contact your healthcare provider for advice on alternative treatment options or a replacement prescription.
- Contact your pharmacy to inform them of the recall and inquire about exchanging your affected medication for a different lot or brand.
- Report any adverse reactions or quality problems you experience while taking this medication to the FDA's MedWatch Adverse Event Reporting program, either online or by phone.
How This Recall Affects You
If you are currently taking Levothyroxine Sodium Tablets 150 mcg from Macleods Pharma USA, Inc., you're probably wondering how this recall directly affects you. If your medication is from the specific lot mentioned (Lot 16240062A), there's a chance that the tablets won't be as effective as they should be. It's important to remember that the agency confirmed that the company is working to resolve the problem. Don't just stop taking your medication without talking to your doctor first! They can help you figure out the best course of action to ensure your thyroid condition remains properly managed.
It can seem scary to find out about a medication recall. If you've been feeling off or experiencing unusual symptoms, this recall might be why. Talk to your doctor about your concerns and get your thyroid levels checked. They can help you adjust your dosage or switch to a different brand if needed. This ensures you get the right amount of medication to manage your health.
While this is the only current recall from Macleods Pharma USA, Inc. that impacts the U.S., the FDA regularly issues recalls for various products. Knowing that the FDA has issued several pharmaceutical recalls recently in 2026, it underscores the importance of staying informed about product safety.
Frequently Asked Questions
Q: What does "subpotent" mean in this recall?
Subpotent means the tablets might not contain the full 150 mcg of Levothyroxine Sodium as labeled, making them less effective than prescribed.
Q: What symptoms might I experience if I've been taking a subpotent dose of Levothyroxine?
Symptoms of hypothyroidism, such as fatigue, weight gain, constipation, and increased sensitivity to cold, may reappear or worsen if your dosage is too low.
Q: Where was this medication sold across the U.S.?
The affected lot was distributed nationwide, meaning it could have been dispensed at pharmacies in any state. It's not linked to any specific retailers like Walmart, Target, Amazon, or Costco.
Q: What should I tell my doctor about this recall?
Inform your doctor that you've been taking Levothyroxine Sodium Tablets from lot number 16240062A, and discuss your concerns about potential subpotency and the need to adjust your dosage or switch to an alternative medication.
Q: Can I get a refund for the recalled medication?
Contact your pharmacy for information on how to return the affected medication and receive a replacement or refund. You can also contact Macleods Pharma USA, Inc. directly for further assistance.
This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.
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Stop using it right away and follow the steps above. You may be entitled to a full refund, free repair, or replacement at no cost.