Levothyroxine Sodium Tablets Recalled for Subpotency Nationwide
Accord Healthcare is recalling 82,159 bottles of Levothyroxine Sodium Tablets (25 mcg) nationwide because the active ingredient levels are below the approved specification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (subpotent prescription medication could affect patient health) with no reported illnesses or injuries documented in the source. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg) in 90-count bottles because the active ingredient assay is below the FDA-approved specification.
The recall affects 82,159 bottles distributed nationwide. The affected lots are Lot #D2300325 (expiration 01/31/2026) and Lot #D2400536 (expiration 02/28/2026). Levothyroxine sodium is a prescription medication. When the active ingredient assay is below specification, the tablets may not meet the intended potency.
Consumers or healthcare providers who have these medications should contact Accord Healthcare or consult their healthcare provider for instructions. Patients should not stop taking levothyroxine without medical guidance.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug
- Hazard
- subpotency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #D2300325
- Exp Date: 01/31/2026
- Lot #D2400536
- Exp Date: 02/28/2026
UPCs (12)
- 0316729447157
- 0316729449151
- 0316729452151
- 0316729454155
- 0316729453158
- 0316729448154
- 0316729451154
- 0316729457156
- 0316729450157
- 0316729456159
- 0316729458153
- 0316729455152
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LEVOTHYROXINE SODIUM
- HighLevothyroxine Sodium Tablets Recalled Nationwide for Subpotent Content
FDA (Drugs) · 2026-04-01
- HighLevothyroxine Tablets Recall for Wrong Strength Product Mix-Up
FDA (Drugs) · 2026-01-21
- HighLevothyroxine Sodium Tablets Recalled for Subpotency Issue Nationwide
FDA (Drugs) · 2025-10-15
- ModerateLevothyroxine Sodium Tablets Recalled Due to Subpotent Drug Content
FDA (Drugs) · 2025-07-23
- HighLevothyroxine Sodium Tablets Recalled Due to Below-Specification Potency
FDA (Drugs) · 2025-07-23
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27