CLASS II Drug recall · Reported 3 Oct 2012 · FDA Enforcement Report
Synthroid (levothyroxine sodium) Tablets USP, 75 mcg recalled
Abbott Laboratories is recalling Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, distributed nationwide in the US. The recall was initiated on 19 Jul 2012 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-1695-2012
- FDA event ID
- 62674
- Recalling firm
- Abbott Laboratories, Abbott Park, IL
- Brand
- Synthroid
- Manufacturer
- AbbVie Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jul 2012
- FDA classified
- 26 Sep 2012
- Reported
- 3 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 19 Jul 2012 | Recall initiated by company | |
| 26 Sep 2012 | Classified by FDA | +69 days |
| 3 Oct 2012 | 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
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
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
Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Which lots are affected?
Lot: 18353A8, Exp 08/31/2013
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 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
2 other products · FDA event 62674This product is part of a recall event; the main page for the event is Synthroid (levothyroxine sodium) Tablets USP, 112 mcg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Synthroid (levothyroxine sodium) Tablets USP, 112 mcg recalledSynthroid | Abbott Laboratories | Potency & Assay | Nationwide | |
| CLASS II | Synthroid (levothyroxine sodium) Tablets USP, 50 mcg recalledSynthroid | Abbott Laboratories | Potency & Assay | Nationwide |
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Other Levothyroxine recalls
All 135| 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 |