FDA Recall D-0403-2026
MACLEODS PHARMA USA, INC · Princeton, NJ
Class II Ongoing 77 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Subpotent Drug
Recall record
- Recall number
D-0403-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2026-02-26
- Classified by FDA Center
- 2026-03-24
- FDA published
- 2026-04-01
- Recalling firm
- MACLEODS PHARMA USA, INC
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- LEVOTHYROXINE SODIUM
- Generic name(s)
- LEVOTHYROXINE SODIUM
- Manufacturer(s)
- Macleods Pharmaceuticals Limited
- NDC(s)
33342-393, 33342-394, 33342-395, 33342-396, 33342-397, 33342-398, 33342-399, 33342-400, 33342-401, 33342-402, 33342-403, 33342-404- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.