Levothyroxine Sodium Tablet
FDA Recall NDC 33342-397
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Levothyroxine Sodium (NDC 33342-397). A significant event, classified as Class II, was initiated on Feb 26, 2026 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Subpotent Drug"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Subpotent Drug
Feb 26, 2026
Apr 01, 2026
1315 bottles
Recall Profile & Regulatory Data
Event ID
98510
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
MACLEODS PHARMA USA, INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# Lot 16240062A, exp date 3/2026
Affected Packages Involved in this Recall
33342-393-10Product
33342-393-11Product
33342-393-44Product
33342-394-10Product
33342-394-11Product
33342-394-44Product
33342-395-10Product
33342-395-11Product
33342-395-44Product
33342-396-10Product
33342-396-11Product
33342-396-44Product
33342-397-10Product
33342-397-11Product
33342-397-44Product
33342-398-10Product
33342-398-11Product
33342-398-44Product
33342-399-10Product
33342-399-11Product
33342-399-44Product
33342-400-10Product
33342-400-11Product
33342-400-44Product
33342-401-10Product
33342-401-11Product
33342-401-44Product
33342-402-10Product
33342-402-11Product
33342-402-44Product
33342-403-10Product
33342-403-11Product
33342-403-44Product
33342-404-10Product
33342-404-11Product
33342-404-44Product
Class III Ongoing
Presence of a foreign substance: black hair found embedded in tablet.
May 29, 2025
Jun 18, 2025
1,344- 1000 count bottles
Recall Profile & Regulatory Data
Event ID
96979
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Macleods Pharmaceuticals Ltd
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# : MLF2401A, Exp 01/31/2026
Affected Packages Involved in this Recall
33342-393-10Product
33342-393-11Product
33342-393-44Product
33342-394-10Product
33342-394-11Product
33342-394-44Product
33342-395-10Product
33342-395-11Product
33342-395-44Product
33342-396-10Product
33342-396-11Product
33342-396-44Product
33342-397-10Product
33342-397-11Product
33342-397-44Product
33342-398-10Product
33342-398-11Product
33342-398-44Product
33342-399-10Product
33342-399-11Product
33342-399-44Product
33342-400-10Product
33342-400-11Product
33342-400-44Product
33342-401-10Product
33342-401-11Product
33342-401-44Product
33342-402-10Product
33342-402-11Product
33342-402-44Product
33342-403-10Product
33342-403-11Product
33342-403-44Product
33342-404-10Product
33342-404-11Product
33342-404-44Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
