Class I · High risk
Thyroid Tablets
Superpotent Drug
Levothyroxine and Liothyronine
Class I — High risk. Reasonable probability of serious harm or death.
Why it was 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.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Affected NDC
69367-0159-04
Compare with the code on your package — it is the most precise check available.
Drug: Levothyroxine Category: Thyroid Medication
- Recalling firm
- Westminster Pharmaceuticals LLC
- NDC code
- 69367-159-04
- Origin
- MS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1181-2018 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Levothyroxine recalls
See all
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Other recalls by Westminster Pharmaceuticals LLC
All 2018 recalls
Class II · Moderate risk
Metoprolol Tartrate Tablets
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II · Moderate risk
Metoprolol Tartrate Tablets
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II · Moderate risk
Westminster Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk
Westminster Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.