CLASS II ONGOING Drug recall · Reported 1 Apr 2026 · FDA Enforcement Report

Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma Usa

Macleods Pharma USA is recalling Levothyroxine Sodium Tablets USP 150 mcg, distributed nationwide in the US. The recall was initiated on 26 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 16240062A, exp date 3/2026

NDC33342-393, 33342-394, 33342-395, 33342-396, 33342-397, 33342-398

UPC0333342393104, 0333342397102, 0333342404107, 0333342393111, 0333342400109, 0333342403100

Quantity recalled1315 bottles

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-0403-2026
FDA event ID: 98510
Recalling firm: Macleods Pharma USA, Princeton, NJ
Brand: Levothyroxine Sodium
Manufacturer: Macleods Pharmaceuticals Limited
Classification: Class II
Status: Ongoing
Recall initiated: 26 Feb 2026
FDA classified: 24 Mar 2026
Reported: 1 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Thyroid Medication

Timeline

26 Feb 2026	Recall initiated by company
24 Mar 2026	Classified by FDA	+26 days
1 Apr 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent Drug

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Subpotent Drug

Which lots are affected?

Lot 16240062A, exp date 3/2026

Where was it sold?

Nationwide

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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 Pharma USA

All 34

Reported	Class	Recall	Company	Reason	Where
22 May 2024Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma USA	Foreign Material	Nationwide
25 Jan 2023Drug	CLASS III	Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa	Macleods Pharma USA	Packaging Defects	Nationwide
13 Jul 2022Drug	CLASS II	Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone	Macleods Pharma Usa	Packaging Defects	Nationwide
6 Jul 2022Drug	CLASS II	Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide
11 May 2022Drug	CLASS II	Losartan Potassium & Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide

Other Levothyroxine recalls

All 145

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide