CLASS II Drug recall · Reported 29 May 2013 · FDA Enforcement Report
Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg recalled
King Legacy, a wholly owned subsidiary of Pfizer is recalling Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, distributed nationwide in the US. The recall was initiated on 30 Apr 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-429-2013
- FDA event ID
- 65172
- Recalling firm
- King Legacy, a wholly owned subsidiary of Pfizer, Bristol, TN
- Brand
- Levoxyl
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2013
- FDA classified
- 20 May 2013
- Reported
- 29 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 30 Apr 2013 | Recall initiated by company | |
| 20 May 2013 | Classified by FDA | +20 days |
| 29 May 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Which lots are affected?
Lot # a) 65066, Exp. 5/13 and 65644, Exp. 7/13; b) 64327, Exp. 4/13 and 65772, Exp. 7/13
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 65172This product is part of a recall event; the main page for the event is Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg recalled.
More recalls from King Legacy, a wholly owned subsidiary of Pfizer
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg recalledLevoxyl | King Legacy, a wholly owned subsidiary of Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg recalledLevoxyl | King Legacy, a wholly owned subsidiary of Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg recalledLevoxyl | King Legacy, a wholly owned subsidiary of Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg recalledLevoxyl | King Legacy, a wholly owned subsidiary of Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg recalledLevoxyl | King Legacy, a wholly owned subsidiary of Pfizer | Potency & Assay | Nationwide |
Other Levothyroxine recalls
All 145| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |