Levothyroxine Sodium Tablets Recalled for Subpotency by Accord Healthcare
Accord Healthcare is recalling 4,888 bottles of Levothyroxine Sodium Tablets (25 mcg) nationwide due to subpotency. The affected lot is D2300323 with expiration date 01/2026.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or adverse events mentioned in the source. The hazard (subpotency) is theoretical and does not meet the threshold for High or above per the rubric.
Plain-English summary
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg) due to subpotency. The recall affects 4,888 bottles from lot D2300323 (expiration date 01/2026) distributed nationwide in the United States. The product was manufactured by Intas Pharmaceuticals Limited in India and distributed under NDC 16729-447-17 and related package NDCs.
Levothyroxine is a prescription thyroid hormone replacement therapy. Subpotent tablets contain less active ingredient than labeled, which could result in inadequate hormone replacement and potential thyroid dysfunction if patients are not monitored appropriately.
This is a voluntary recall initiated by the firm. Consumers should contact their healthcare provider or pharmacist if they have received this medication. Do not stop taking levothyroxine without speaking to a doctor, as abrupt discontinuation can cause serious health effects. Consumers may also report adverse reactions or product quality concerns to the FDA.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Hazard
- subpotency
- inadequate-drug-strength
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 # D2300323
- Exp Date: 01/2026
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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