Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 125 mcg tablets because they are subpotent. The recall is ongoing nationwide.
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 High (3).
Plain-English summary
Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles. The recall was initiated on August 6, 2026, and is currently ongoing. The affected product is manufactured by Intas Pharmaceuticals Limited in India and distributed nationwide within the United States.
The reason for the recall is that the drug is subpotent, meaning it may not contain the full labeled amount of the active ingredient. The FDA has classified this recall as Class II, which indicates a situation that could cause temporary or medically reversible health consequences. The specific lots affected are D2401983 (Exp. 08/31/2026), D2402640 and D2402641 (Exp. 11/30/2026), and D2500224 (Exp. 01/31/2027).
Consumers and healthcare providers should check their medication bottles for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or contact Accord Healthcare for instructions. The recall number is D-0781-2026.
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 (7)
- Lot #: D2401983
- Exp. Date 08/31/2026
- D2402640
- D2402641
- Exp. Date 11/30/2026
- D2500224
- Exp. Date 01/31/2027.
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
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
Same manufacturer · ACCORD HEALTHCARE, INC.
See all →- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- ModerateAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
Same hazard · subpotent drug
See all →- LowImprimisRx Recalls Subpotent Povidone Iodine and Proparacaine Ophthalmic Solution
FDA (Drugs) · 2026-09-16
Similar recalls
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- ModerateLevothyroxine Sodium Tablets Nationwide Recall Due to Subpotency
FDA (Drugs) · 2025-05-07
- ModerateLevothyroxine Sodium 300 mcg Tablets Recalled for Subpotency
FDA (Drugs) · 2026-07-08
- ModerateLevothyroxine Sodium Tablets 50 mcg Recalled for Subpotency
FDA (Drugs) · 2025-05-07