Recalls / Class II
Class IID-0403-2026
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
- Brand name
- Levothyroxine Sodium
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 33342-393, 33342-394, 33342-395, 33342-396, 33342-397, 33342-398, 33342-399, 33342-400, 33342-401, 33342-402 +2 more
- FDA application
- ANDA211417
- Affected lot / code info
- Lot 16240062A, exp date 3/2026
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- MACLEODS PHARMA USA, INC
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 103 College Rd E Fl 2, Princeton, New Jersey 08540-6611
Distribution
- Quantity
- 1315 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2026-02-26
- FDA classified
- 2026-03-24
- Posted by FDA
- 2026-04-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0403-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.