Home/Recalls/FDA-D-0403-2026
FDA DrugsClass II

Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufact...

Published: April 1, 2026Recall ID: D-0403-2026Category: drugsCountry: US

Reason for Recall / Hazard

Subpotent Drug

Product Description & Identification

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

Additional Source Details

FieldValue
CityPrinceton
StateNJ
Openfda › Upc › 10333342393104
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Openfda › Unii9J765S329G
Openfda › RouteORAL
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Openfda › Spl id3a77ca51-7d8a-4755-aabc-3801cc772a10
Openfda › Brand nameLEVOTHYROXINE SODIUM
Openfda › Spl set idb8c20f76-3ee6-4b29-b77f-ed4ad1baaed9
Openfda › Package ndc › 133342-393-10
Openfda › Package ndc › 233342-393-11
Openfda › Package ndc › 333342-393-44
Openfda › Package ndc › 433342-394-10
Openfda › Package ndc › 533342-394-11
Openfda › Package ndc › 633342-394-44
Openfda › Package ndc › 733342-395-10
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Openfda › Package ndc › 933342-395-44
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Openfda › Package ndc › 1133342-396-11
Openfda › Package ndc › 1233342-396-44
Openfda › Package ndc › 1333342-397-10
Openfda › Package ndc › 1433342-397-11
Openfda › Package ndc › 1533342-397-44
Openfda › Package ndc › 1633342-398-10
Openfda › Package ndc › 1733342-398-11
Openfda › Package ndc › 1833342-398-44
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Openfda › Package ndc › 3133342-403-10
Openfda › Package ndc › 3233342-403-11
Openfda › Package ndc › 3333342-403-44
Openfda › Package ndc › 3433342-404-10
Openfda › Package ndc › 3533342-404-11
Openfda › Package ndc › 3633342-404-44
Openfda › Product ndc › 133342-393
Openfda › Product ndc › 233342-394
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Openfda › Product ndc › 433342-396
Openfda › Product ndc › 533342-397
Openfda › Product ndc › 633342-398
Openfda › Product ndc › 733342-399
Openfda › Product ndc › 833342-400
Openfda › Product ndc › 933342-401
Openfda › Product ndc › 1033342-402
Openfda › Product ndc › 1133342-403
Openfda › Product ndc › 1233342-404
Openfda › Generic nameLEVOTHYROXINE SODIUM
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance nameLEVOTHYROXINE SODIUM
Openfda › Manufacturer nameMacleods Pharmaceuticals Limited
Openfda › Application numberANDA211417
Openfda › Is original packagertrue
Event id98510
Address 1103 College Rd E Fl 2
Code infoLot 16240062A, exp date 3/2026
Postal code08540-6611
Report date20260401
Product typeDrugs
Product quantity1315 bottles
Reason for recallSubpotent Drug
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260226
Initial firm notificationLetter
Center classification date20260324

Overview

  • Recalling FirmMACLEODS PHARMA USA, INC
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide
Official Agency Alert