CLASS II Drug recall · Reported 24 Apr 2013 · FDA Enforcement Report
Levoxyl (levothyroxine sodium) tablets, USP 150 mcg recalled by Pfizer
Pfizer is recalling Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, distributed nationwide in the US. The recall was initiated on 28 Mar 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-259-2013
- FDA event ID
- 64835
- Recalling firm
- Pfizer, New York, NY
- Brand
- Levoxyl
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 28 Mar 2013
- FDA classified
- 18 Apr 2013
- Reported
- 24 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Thyroid Medication
Timeline
| 28 Mar 2013 | Recall initiated by company | |
| 18 Apr 2013 | Classified by FDA | +21 days |
| 24 Apr 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical contamination: emission of strong odor after package was opened.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
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 PR
Questions about this recall
Is Levoxyl (levothyroxine sodium) tablets, USP 150 mcg recalled?
Yes. Pfizer recalled Levoxyl (levothyroxine sodium) tablets, USP 150 mcg on 28 Mar 2013. The recall is Class II and its status is Completed. Recall number D-259-2013.
Why was it recalled?
Chemical contamination: emission of strong odor after package was opened.
Which lots are affected?
Lot # a) 66375B, Exp. 10/13; 66719B, Exp. 01/14; b) 66904B, Exp. 01/14
Where was it sold?
Nationwide and PR
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Levothyroxine recalls
All 114| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg 112 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 88 mcg 088 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 100 mcg 1 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 175 mcg 175 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg 15 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |