FDA Recalls Thousands of Blood Pressure Medication Bottles

The U.S. Food and Drug Administration (FDA) is asking consumers to check their medicine cabinets following a nationwide recall of thousands of blood pressure medication bottles. The recall involves certain lots of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets manufactured by New Jersey-based Macleods Pharma USA.

Details of the Macleods Pharma USA Recall

The FDA issued the recall on Oct. 7, 2026, and later instituted a Class II rating on Oct. 26, 2026. According to the FDA, a Class II recall means the use of the affected medication may cause "temporary or medically reversible adverse health consequences," though the likelihood of serious consequences is considered remote.

The recall includes a total of 3,744 bottles:

• 3,528 30-count bottles from lot 12251163A (NDC 33342-246-07)
• 216 90-count bottles from lot 12251163B (NDC 33342-246-10)

Both affected lots have an expiration date of May 31, 2027. An enforcement report stated the medication failed to meet quality standards because the pills did not dissolve as required during testing. This failure to meet "failed dissolution specifications" means the medication may not release its active ingredients at the required rate after being taken, which could potentially affect how much of the drug the body absorbs.

Additional Medication Recalls

The FDA has also announced a Class III recall regarding Viatris Inc.'s combination telmisartan and amlodipine tablets. This recall involves 21,620 bottles of 30-count tablets (40 mg/5 mg) that may contain more telmisartan than specified. The affected lots include:

• Lots 3228113, 3228114 and 3228115 (expiring October 31)
• Lots 3228120 and 3228121 (expiring November 30)

A Class III recall means the use of the affected product is not likely to cause adverse health consequences. However, the National Library of Medicine warns that an overdose of telmisartan could cause low blood pressure, dizziness, or a rapid heart rate.

Additionally, Inventia Healthcare recalled certain lots of chlorthalidone tablets in June. On Sept. 3, 2026, the company initiated a separate recall involving an additional lot, which the FDA classified as a Class II recall on Sept. 17, 2026. This recall involved 13,567 bottles of 25-milligram tablets.

Why it matters

For patients managing hypertension, the FDA advises that they should not stop taking prescribed blood pressure medication without consulting a healthcare provider, as abruptly discontinuing treatment may pose additional health risks. Consumers who find matching lot numbers or National Drug Codes (NDC) on their prescription bottles should contact their doctor or pharmacist for guidance on whether to continue the medication or switch to an alternative.

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Sources

• wmur.com: FDA recalls thousands of blood pressure bottles after it failed quality tests - WMUR
• wcvb.com: FDA recalls thousands of blood pressure bottles after it failed quality tests - WCVB
• journalarta.com: FDA Recalls Macleods Blood Pressure Tablets After Quality Test Failure — JournalArta Global
• healthandme.com: US FDA Recalls Thousands Of Blood Pressure Drugs Over Excess Drug Levels, Failed Quality Tests | Health and Me
• m.economictimes.com: Blood pressure drug recall: FDA flags thousands of bottles after pills fail quality tests; here's what to check - The Economic Times
• foxbusiness.com: Blood pressure medicine recall: Thousands of bottles pulled nationwide | Fox Business

This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.