CLASS I Drug recall · Reported 29 Aug 2018 · FDA Enforcement Report
Levothyroxine and Liothyronine (Thyroid Tablets, USP) recalled
Westminster Pharmaceuticals is recalling Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), distributed nationwide in the US. The recall was initiated on 3 Aug 2018 and the FDA has classified it as Class I.
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-1181-2018
- FDA event ID
- 80719
- Recalling firm
- Westminster Pharmaceuticals, Olive Branch, MS
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Aug 2018
- FDA classified
- 7 Sep 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Thyroid Medication
Timeline
| 3 Aug 2018 | Recall initiated by company | |
| 29 Aug 2018 | Published in enforcement report | +26 days |
| 7 Sep 2018 | Classified by FDA | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Product as listed by the FDA
Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-159-04.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Which lots are affected?
Lot #: 15917VP03, 15917VP02, 15917VP01, Exp 10/31/2019; 15918004, 15918003, 15918002, 15918001, Exp 12/31/2019; 15918VP03, 15918VP02, 15918VP01, 15918005, Exp 2/29/2020; 15918007, 15918006, Exp 3/31/2020.
Where was it sold?
Nationwide in the USA 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
4 other products · FDA event 80719This product is part of a recall event; the main page for the event is Levothyroxine and Liothyronine (Thyroid Tablets, USP) recalled.
More recalls from Westminster Pharmaceuticals
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoprolol Tartrate Tablets, USP, 50 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metoprolol Tartrate Tablets, USP, 100 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Westminster Irbesartan Tablets, USP 150 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Westminster Irbesartan Tablets, USP 300 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Westminster Irbesartan Tablets, USP 75 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |
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 |