Levothyroxine Sodium Tablets 88 mcg Recall for Subpotency
Accord Healthcare is recalling Levothyroxine Sodium Tablets 88 mcg (Lot D2300044, expiring 12/2025) nationwide because the tablets are subpotent—below the required strength. Patients on this medication should contact their pharmacy or prescriber.
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: FDA Class II applies; however, the source explicitly states "Voluntary: Firm initiated" and does not report any illnesses or hospitalizations. The hazard is a high-risk condition (subpotent thyroid hormone) where therapeutic failure and potential adverse health effects are possible without reported incidents, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Accord Healthcare, Inc. is voluntarily recalling 4,885 bottles of Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), marketed under NDC 16729-450-17 and related NDCs. The recall affects Lot # D2300044, with expiration date 12/2025, distributed nationwide in the United States. The tablets are subpotent, meaning they contain less active ingredient than specified and labeled.
Levothyroxine sodium is a prescription thyroid hormone replacement medication. Subpotent tablets may not provide adequate therapeutic effect, potentially resulting in inadequate treatment of hypothyroidism or other thyroid conditions for which the medication was prescribed.
Patients taking Levothyroxine Sodium Tablets from the recalled lot should not stop taking their medication without guidance from their healthcare provider. Patients should contact their pharmacy or prescriber to obtain replacement medication and discuss any symptoms or concerns related to insufficient thyroid hormone levels. The recall was initiated on April 10, 2025, and the FDA classified it as Class II on April 30, 2025.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Hazard
- subpotency
- therapeutic-failure
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.
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