Class I · High risk
Thyroid Tablets
Superpotent Drug
Levoxyl (levothyroxine sodium)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug: The products were below specification for potency at the expiry stability point.
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
Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Affected NDCs
60793-0855-01
60793-0855-10
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.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Levoxyl levothyroxine sodium NDC 60793-0855 |
112 ug/1 | Tablet Oral |
Pfizer Laboratories Div Pfizer Inc | Rx |
- Recalling firm
- King Legacy, a wholly owned subsidiary of Pfizer
- NDC code
- 60793-855-01
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-426-2013 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Levothyroxine recalls
See all
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Other recalls by King Legacy, a wholly owned subsidiary of Pfizer
All 2013 recalls
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
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