Macleods Pharma USA is recalling olmesartan combination tablets nationwide. Here are the lot numbers, NDCs and what the FDA says.

Macleods Pharma USA is recalling 3,744 bottles of a combination anti-hypertensive medication, Olmesartan.

This was a voluntary action by Macleods on October 7th, however has become an official class II recall by the FDA on October 26th. Two batches of tablets will be recalled which contain Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide. Both batches will have an expiry date of May 31st 2027. This is an ongoing recall meaning the tablets have been distributed nationally.

What is the issue?

The New Jersey based pharmaceutical company is recalling 3,528 bottles (30 tablets) and 216 bottles (90 tablets). The batch numbers are 12251163A (30 tablets) and 12251163B (90 tablets). NDC codes are 33342-246-07 (30 tablets) and 33342-246-10 (90 tablets). These can be found on your prescription bottle. It is an ongoing recall so you may have some of these tablets in your cabinet.

Why is the tablet being recalled?

The FDA states that they "did not meet the dissolution specifications". This means that the tablets did not dissolve in the laboratory correctly. As the two batches of tablets contained Olmesartan, this did not meet the requirements of the tablet. This could cause temporary issues with controlling blood pressure as not as much of the tablet is being taken. Tablets that do not dissolve correctly may not deliver the correct dose.

How bad is a class II recall?

This is not the worst thing that could happen from the agency. The FDA state that they "may result in temporary or medically reversible adverse health consequences." This means that it is unlikely to cause any serious issues. This is in the middle of the three categories the FDA use.

What should patients do?

If the batch number and NDC code match please contact your pharmacist or prescriber. However, do not stop taking your antihypertensives.

Has anything else been recalled?

In September, Inventia Healthcare Ltd recalled 13,567 bottles of their 25mg Chlorthalidone tablets. This was due to failure to dissolve. Macleods could not be contacted by Fox Business immediately.

More information

Olmesartan Medoxomil is an Angiotensin II Receptor Blocker which will reduce blood pressure.

Ascend Laboratories have also recalled 15,696 bottles of Amlodipine and Olmesartan Medoxomil Tablets 5 mg/40 mg. They are also a class II recall due to failure to dissolve. Olmesartan levels were substandard.

The FDA have also issued a class III recall on 21,620 bottles of Viatris Telmisartan and Amlodipine Tablets. These may contain increased levels of Telmisartan.

Class III recalls are unlikely to cause any adverse health consequences.

Only 2 batches of tablets (3,744 bottles) have been recalled as they failed one of the lab tests. As this is a medication taken daily by hypertensive patients it is important to know that the dose may not be as effective. Business Fortune asks readers to please check if your batch number matches and contact your pharmacist.

FAQs

Is Olmesartan being recalled?

No only specific batches of the combination tablet produced by Macleods Pharma USA.

What batches are being recalled?

Batch 12251163A (NDC code 33342-246-07 (30 tablets)) and Batch 12251163B (NDC code 33342-246-10 (90 tablets)). Both have an expiry date of May 31st 2027.

What does not meeting dissolution specifications mean?

The tablets did not dissolve correctly. This can affect how much of the drug is absorbed.

What does class II mean?

It may cause temporary or medically reversible health issues. Serious issues are unlikely.

What should I do if my batch matches?

Contact your pharmacist.

Sources

Fox Business · KTBS · Health and Me · HMP Global Learning Network