Health · Pharma & Biotech · 3 hrs ago
FDA classifies nationwide recall of 3,744 blood pressure medication bottles
Macleods Pharma USA recalled 3,744 bottles of a generic blood pressure medicine distributed across the United States.
The tablets combine olmesartan medoxomil, amlodipine and hydrochlorothiazide, and are a generic version of Tribenzor.
The affected bottles are from two lots: 3,528 bottles with 30 tablets and 216 bottles with 90 tablets.
The pills failed a test of how they dissolve, so their active ingredients may not release in the body at the required rate.
The FDA classified the recall as Class II, meaning the medicine may cause temporary or medically reversible health effects; it says the likelihood of serious harm is considered remote.
Check the bottle's lot number and NDC against the FDA's listed details: lot 12251163A, NDC 33342-246-07, for 30-count bottles, or lot 12251163B, NDC 33342-246-10, for 90-count bottles; both expire May 31, 2027.
Contact your prescribing doctor before stopping the medicine, and speak with a doctor if you have health concerns; the FDA has not issued specific instructions for consumers.
Macleods Pharma USA is recalling 3,744 bottles of a combination blood pressure medication after the pills failed dissolution specifications.
The nationwide recall covers 3,528 30-count bottles and 216 90-count bottles of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets.
The FDA classified the recall as Class II on October 26, saying use may cause temporary or medically reversible adverse health consequences.
Macleods initiated the voluntary recall on October 7, and both affected lots expire May 31, 2027.
The FDA had not issued specific instructions for consumers, and Prevention advised patients to contact their prescriber before stopping the medication.
- Who
- Macleods Pharma USA, Inc. initiated the recall; the FDA classified it.
- What
- A recall covers 3,744 bottles of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets after the pills failed dissolution specifications.
- When
- Macleods initiated the recall on October 7, 2026; the FDA classified it on October 26.
- Where
- Nationwide in the United States.
- Why
- The medication failed dissolution specifications, meaning the pills did not dissolve as required during testing.
This story does not have two clearly opposing sides.
India-based Inventia Healthcare Ltd. recalled 13,567 bottles of chlorthalidone tablets after they failed dissolution testing.
Macleods Pharma USA initiated the voluntary recall.
The FDA classified the recall as Class II.
- Total bottles
- 3,744
- 30-count bottles
- 3,528; lot 12251163A; NDC 33342-246-07
- 90-count bottles
- 216; lot 12251163B; NDC 33342-246-10
- Expiration date
- May 31, 2027
- Recall classification
- Class II
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What people are saying
failed dissolution specifications
may cause temporary or medically reversible adverse health consequences