CLASS II ONGOING Drug recall · Reported 28 Oct 2026 · FDA Enforcement Report
Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg recalled
Pfizer is recalling Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, distributed nationwide in the US. The recall was initiated on 29 Sep 2026 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-0051-2027
- FDA event ID
- 99963
- Recalling firm
- Pfizer, Manhattan, NY
- Brand
- Levoxyl
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Sep 2026
- FDA classified
- 16 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 29 Sep 2026 | Recall initiated by company | |
| 16 Oct 2026 | Classified by FDA | +17 days |
| 28 Oct 2026 | Published in enforcement report | +12 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: confirmed out-of-specification (OOS) assay during stability testing.
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), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10
Where it was distributed
US Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
Which lots are affected?
Lot # 24W07, Exp: 11/30/2026
Where was it sold?
US 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 3 Nov 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
1 other product · FDA event 99963This product is part of a recall event; the main page for the event is Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg recalledLevoxyl | Pfizer | Potency & Assay | Nationwide |
More recalls from Pfizer
All 129| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg recalledLevoxyl | Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalledDopamine Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
Other Levothyroxine recalls
All 137| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg recalledLevoxyl | Pfizer | Potency & Assay | Nationwide |
| 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 |