← FDA ENFORCEMENT
D-0403-2026Class II

MACLEODS PHARMA USA, INC

Recalling firm
MACLEODS PHARMA USA, INC
Product type
Drug
Status
Ongoing
Report date
2026-04-01
Distribution
Nationwide
Firm state
NJ
Product quantity
1315 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent Drug

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

Code / lot info

Lot 16240062A, exp date 3/2026

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.