CLASS III ONGOING Drug recall · Reported 15 Nov 2023 · FDA Enforcement Report
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg) recalled
AbbVie is recalling Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg). The recall was initiated on 17 Oct 2023 and the FDA has classified it as Class III.
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-0088-2024
- FDA event ID
- 93202
- Recalling firm
- AbbVie, North Chicago, IL
- Brand
- Synthroid
- Manufacturer
- AbbVie Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 17 Oct 2023
- FDA classified
- 5 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Thyroid Medication
Timeline
| 17 Oct 2023 | Recall initiated by company | |
| 5 Nov 2023 | Classified by FDA | +19 days |
| 15 Nov 2023 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Product as listed by the FDA
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
Where it was distributed
Distributed in the US. No government or foreign consignees.
Questions about this recall
Why was it recalled?
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Which lots are affected?
Lot # 1187435 exp date: 02/2024
Where was it sold?
Distributed in the US. No government or foreign consignees.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from AbbVie
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pred Mild, prednisolone acetate ophthalmic suspension recalled by AbbViePred Mild | AbbVie | Potency & Assay | Nationwide |
| Drug | CLASS II | Refresh Lacri-lube, (42.5% Mineral Oil recalled by AbbVie | AbbVie | Sterility | Nationwide |
| Drug | CLASS II | Refresh P.M., (Mineral Oil recalled by AbbVie | AbbVie | Sterility | Nationwide |
| Drug | CLASS III | Ultane (sevoflurane), Inhalation Anesthetic recalled by AbbVieUltane | AbbVie | Packaging Defects | MS, OH |
| Drug | CLASS III | AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump recalled | AbbVie | Temperature Abuse | AZ |
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 |