Accord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 100 mcg tablets because they may contain less active ingredient than labeled.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe), particularly when involving critical medications like thyroid hormones where subpotency can lead to significant health consequences.
Plain-English summary
Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg). The recall covers 90-count bottles (NDC 16729-451-15) and 1000-count bottles (NDC 16729-451-17) distributed nationwide within the United States. The specific lots affected are D2402186 (Exp. 09/30/2026), D2402019 (Exp. 08/31/2026), D2402094 (Exp. 09/30/2026), D2500022, D2500023, and D2500021 (Exp. 12/31/2026).
The reason for the recall is that the product is subpotent, meaning it may contain less of the active drug ingredient than stated on the label. The FDA has classified this as a Class II recall, which indicates a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients taking this medication should check their bottles for the affected lot numbers and expiration dates. If the medication matches the recalled lots, consumers should stop using it and contact their pharmacist or physician for guidance on obtaining a replacement. The recall was initiated by the firm on August 6, 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 (9)
- a) Lot #: D2402186
- Exp. Date 09/30/2026. b) Lot #: D2402019
- Exp. Date 08/31/2026
- D2402094
- Exp. Date 09/30/2026
- D2500022
- D2500023
- D2500021
- Exp. Date 12/31/2026.
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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