The Recall Desk
SevereFDA (Drugs)·D-0785-2026·Announced 2026-09-02

Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide

Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 200 mcg tablets because they are subpotent. The recall covers distribution nationwide in the United States.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a subpotent drug (which implies a risk of therapeutic failure) is categorized as Severe (Score 4), as it is not a Class I recall but involves a significant potential for adverse health consequences due to lack of efficacy.

Plain-English summary

Accord Healthcare, Inc. is voluntarily recalling Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg). The affected products are packaged in 90-count bottles (NDC 16729-457-15) and 1000-count bottles (NDC 16729-457-17). The recall is initiated because the drug is subpotent, meaning it does not contain the full labeled amount of the active ingredient.

The specific lots affected are D2402430, D2402431, D2402432, and D2500180. These lots have expiration dates of 10/31/2026 and 12/31/2026. The products were distributed nationwide within the United States. The recall was initiated on August 6, 2026, and is currently ongoing.

Consumers and healthcare providers should check their inventory for these specific NDCs and lot numbers. If the product matches the recalled description, it should be returned to the pharmacy or distributor. Patients should consult their healthcare provider regarding alternative treatment options if they have been using the recalled product.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM

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 # D2402430
  • D2402431
  • Exp Date: 10/31/2026. b) Lot #: D2402432
  • Exp. Date 10/31/2026
  • D2500180
  • 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.