Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottles, Rx O...

FDA Drug Recall #D-1181-2018 — Class I — August 3, 2018

Recall Summary

Recall Number D-1181-2018
Classification Class I — Serious risk
Date Initiated August 3, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Westminster Pharmaceuticals LLC
Location Olive Branch, MS
Product Type Drugs
Quantity Unknown

Product Description

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.

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.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Lot / Code Information

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.

Other Recalls from Westminster Pharmaceuticals LLC

Recall # Classification Product Date
D-0582-2025 Class II Metoprolol Tartrate Tablets, USP, 100 mg, 1000 ... Aug 6, 2025
D-0581-2025 Class II Metoprolol Tartrate Tablets, USP, 50 mg, 1000 T... Aug 6, 2025
D-0300-2019 Class II Westminster Irbesartan Tablets, USP 75 mg Rx On... Oct 29, 2018
D-0302-2019 Class II Westminster Irbesartan Tablets, USP 300 mg Rx O... Oct 29, 2018
D-0301-2019 Class II Westminster Irbesartan Tablets, USP 150 mg Rx O... Oct 29, 2018

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.