CLASS II Drug recall · Reported 30 Nov 2016 · FDA Enforcement Report
Levoxyl(R) (levothyroxine sodium tablets, USP), 200 mcg recalled
Pfizer is recalling Levoxyl(R) (levothyroxine sodium tablets, USP), 200 mcg, distributed nationwide in the US. The recall was initiated on 7 Nov 2016 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-0150-2017
- FDA event ID
- 75691
- Recalling firm
- Pfizer, New York, NY
- Brand
- Levoxyl
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Nov 2016
- FDA classified
- 23 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 7 Nov 2016 | Recall initiated by company | |
| 23 Nov 2016 | Classified by FDA | +16 days |
| 30 Nov 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent
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(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01
Where it was distributed
Nationwide
Questions about this recall
Is Levoxyl(R) (levothyroxine sodium tablets, USP), 200 mcg recalled?
Yes. Pfizer recalled Levoxyl(R) (levothyroxine sodium tablets, USP), 200 mcg on 7 Nov 2016. The recall is Class II and its status is Terminated. Recall number D-0150-2017.
Why was it recalled?
Superpotent
Which lots are affected?
16H21, Exp. 08/2017
Where was it sold?
Nationwide
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 |