FDA Recalls Accord Levothyroxine Sodium Tablets Nationwide for Subpotency
Accord Healthcare recalls 4,885 bottles of Levothyroxine Sodium 88 mcg tablets nationwide due to subpotency. Tablets contain less active ingredient than labeled, potentially affecting medication efficacy.
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 FDA Class II recall involves subpotent prescription medication with no reported illnesses or injuries. Per the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Accord Healthcare has initiated a nationwide recall of Levothyroxine Sodium Tablets (88 mcg) due to subpotency. A total of 4,885 bottles from Lot D2300044 with an expiration date of December 2025 are affected.
The tablets contain less active ingredient than labeled. This could affect the therapeutic effectiveness of the medication for patients requiring thyroid hormone replacement therapy.
Patients currently taking this medication should contact their healthcare provider to discuss their individual situation. Do not stop taking levothyroxine without consulting a doctor, as stopping treatment abruptly could cause health complications.
Patients can identify potentially affected bottles by checking for Lot D2300044 and an expiration date of December 2025. Consult your pharmacist or healthcare provider if you have questions about whether your medication is part of this recall.
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 (2)
- Lot # D2300044
- Exp Date: 12/2025
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