CLASS II Drug recall · Reported 29 May 2013 · FDA Enforcement Report
Levothroid (levothyroxine sodium tablets, USP), 100 mcg recalled
Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium tablets, USP), 100 mcg, distributed nationwide in the US. The recall was initiated on 1 Apr 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-445-2013
- FDA event ID
- 65154
- Recalling firm
- Lloyd Inc. of Iowa, Shenandoah, IA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Apr 2013
- FDA classified
- 21 May 2013
- Reported
- 29 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 1 Apr 2013 | Recall initiated by company | |
| 21 May 2013 | Classified by FDA | +50 days |
| 29 May 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
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
Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1323-01
Where it was distributed
The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Which lots are affected?
Lot #: 1095184, 1095185, 1095186, 1095187, Exp Apr-13; 1096370, Exp May-13; 1097547, 1097588, 1097589, Exp Jul-13.
Where was it sold?
The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers 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 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
19 other products · FDA event 65154This product is part of a recall event; the main page for the event is Lloyd Thyro-Tab 0.050 mg recalled by Lloyd Inc. of Iowa.
More recalls from Lloyd Inc. of Iowa
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lloyd Thyro-Tab 0.200 mg recalled by Lloyd Inc. of Iowa | Lloyd Inc. of Iowa | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothroid (levothyroxine sodium tablets, USP), 175 mcg recalled | Lloyd Inc. of Iowa | Potency & Assay | Nationwide |
| Drug | CLASS II | Lloyd Thyro-Tab 0.175 mg recalled by Lloyd Inc. of Iowa | Lloyd Inc. of Iowa | Potency & Assay | Nationwide |
| Drug | CLASS II | Lloyd Thyro-Tab 0.137 mg recalled by Lloyd Inc. of Iowa | Lloyd Inc. of Iowa | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothroid (levothyroxine sodium tablets, USP) , 125 mcg recalled | Lloyd Inc. of Iowa | Potency & Assay | Nationwide |
Other Levothroid (levothyroxine recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothroid (levothyroxine sodium tablets, USP), 175 mcg recalled | Lloyd Inc. of Iowa | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothroid (levothyroxine sodium tablets, USP) , 125 mcg recalled | Lloyd Inc. of Iowa | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothroid (levothyroxine sodium tablets, USP) , 75 mcg recalled | Lloyd Inc. of Iowa | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothroid (levothyroxine sodium tablets, USP), 200 mcg recalled | Lloyd Inc. of Iowa | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothroid (levothyroxine sodium tablets, USP), 88 mcg recalled | Lloyd Inc. of Iowa | Potency & Assay | Nationwide |