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Recall Observatory FDA recall evidence

Drug product

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

D-0403-2026

February 26, 2026

Class II

Product summary

Firm
MACLEODS PHARMA USA, INC
Event
Event 98510
Status
Ongoing
Classification
Class II
Quantity
1315 bottles
Official record key
drug-enforcement:D-0403-2026

Official wording

Reason: Subpotent Drug

Code information: Lot 16240062A, exp date 3/2026

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent