Levothyroxine Sodium 175 mcg Tablets Recalled for Subpotent Assay
Accord Healthcare is recalling 2,344 bottles of Levothyroxine Sodium 175 mcg tablets (Lot #D2300042) nationwide due to subpotency—the drug assay tested below FDA-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 an FDA Class II recall for a subpotent drug with no reported illnesses or injuries. Although subpotency in thyroid replacement therapy presents a risk of reduced therapeutic effect, the absence of reported adverse events supports a 'High' severity classification.
Plain-English summary
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 175 mcg in 1000-count bottles distributed nationwide. The affected lot is #D2300042 (expiration date 12/31/2025). Approximately 2,344 bottles are affected.
The recall was initiated because testing revealed that the drug's assay fell below the FDA-approved specification. This subpotency means the tablets may contain less of the active ingredient levothyroxine than the labeled 175 mcg dose, which could reduce the drug's intended therapeutic effect.
Patients currently taking this medication should consult their healthcare provider or pharmacist immediately. Do not discontinue levothyroxine without medical guidance, as stopping thyroid replacement therapy abruptly can cause serious complications. Contact your pharmacy or healthcare provider if you believe you have the recalled medication.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- 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 #D2300042
- Exp Date: 12/31/2025
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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