Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Aug 6, 2026 (2 months ago)

Levothyroxine Sodium Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Subpotent Drug

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17.

Affected NDC 16729-0453-17

Compare with the code on your package — it is the most precise check available.

Drug: Levothyroxine Category: Thyroid Medication

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Levothyroxine sodium
NDC 16729-0453
125 ug/1 Tablet
Oral
Accord Healthcare Inc. Rx
Recalling firm
Accord Healthcare, INC.
NDC code
16729-453-17
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0781-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other Levothyroxine recalls

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Other recalls by Accord Healthcare, INC.

All 2026 recalls