Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is recalling specific lots of Levothyroxine Sodium 137 mcg tablets because they may contain less than the labeled amount of active ingredient.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II for a subpotent drug. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).
Plain-English summary
Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg). The affected products are packaged in 90-count bottles (NDC 16729-454-15) and 1000-count bottles (NDC 16729-454-17). The tablets were manufactured by Intas Pharmaceuticals Limited in India and distributed nationwide within the United States.
The recall was initiated because the affected lots are subpotent, meaning they may contain less than the labeled amount of the active ingredient. The specific lots involved are D2402125, D2402126, and D2402127 (expiration date 09/30/2026), as well as D2402523 and D2402524 (expiration date 11/30/2026).
Patients who have been prescribed this medication should check their bottles for the NDC numbers and lot numbers listed above. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for a replacement prescription. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug — Prescription Medication
- Hazard
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 (6)
- a) Lot # D2402125
- D2402126
- D2402127
- Exp. Date 09/30/2026. b) Lot #: D2402523
- D2402524
- Exp. Date 11/30/2026.
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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