FDA raises recall level for blood pressure drugs from India

07/13/2025 / By Ramon Tomey

The FDA elevated Granules Pharmaceuticals’ recall of metoprolol succinate from Class III (low risk) to Class II (moderate risk) after failed stability tests, citing potential reduced effectiveness due to dissolution failures in extended-release tablets.
The recall reflects ongoing concerns about overseas facilities, particularly in India, where sanitation failures and contamination risks were highlighted in a February FDA warning letter to Granules.
This incident follows other recent recalls (e.g., carcinogenic impurities in carvedilol), exposing vulnerabilities in global drug supply chains, as roughly 40 percent of U.S. generics originate from India.
Metoprolol is widely prescribed (65M+ U.S. prescriptions in 2022); inconsistent dissolution could compromise cardiovascular treatment, though alternatives may be needed. The FDA advises consulting doctors before discontinuing use.
The recall reignites debates over reliance on overseas manufacturing and the FDA’s oversight capacity, underscoring the precarious balance between affordability and drug safety without structural reforms.

The Food and Drug Administration (FDA) has upgraded its recall designation for hypertension drugs made by Indian drug manufacturer Granules Pharmaceuticals.

On June 24, the regulator announced that Granules – based in India’s Telangana state – recalled more than 33,000 bottles of the widely prescribed blood pressure drug metoprolol succinate. This was originally given a Class III designation, which the FDA defines as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

However, this designation was raised to Class II – the second-highest – on Tuesday, July 8. The FDA said the move followed the recalled products failing mandatory stability tests. The affected lots distributed nationwide contain extended-release tablets that did not meet dissolution standards during routine testing, raising risks of reduced effectiveness.

While the FDA classified the recall as “moderate risk,” it nevertheless deals a serious blow to consumer confidence in generic medications. It also underscores persistent concerns about manufacturing lapses at overseas facilities supplying the American market.

This is not an isolated case.

Earlier this year, the FDA flagged carcinogenic impurities in 700,000 bottles of carvedilol, another beta-blocker. Such recalls highlight systemic vulnerabilities in global drug supply chains, particularly as nearly 40 percent of generic medications consumed in the U.S. originate from India. Regulatory scrutiny has intensified since a 2019 FDA probe found falsified data at multiple Indian plants, yet persistent violations suggest deeper accountability gaps.

From bird droppings to pills: Serious lapses in generic drug manufacturing

The metoprolol succinate recall follows a February warning letter sent by the regulator. The letter signed by the FDA’s Francis Godwin cited sanitation failures, bird droppings in air handling units, and cross-contamination risks at Granules’ Telangana plant.

The timing is particularly alarming, as metoprolol ranks among the most dispensed drugs in the U.S. – with over 65 million prescriptions filled in 2022 alone. Granules, which recently invested $22.3 million to expand into peptide-based drug manufacturing, claims to have resolved the FDA’s earlier observations. However, the agency’s Feb. 26 warning letter painted a starkly different picture, outlining conditions that directly contradict current good manufacturing practices. (Related: What’s killing Americans? Top 10 prescribed medications of 2016 give us a troublesome answer.)

The FDA’s enforcement report did not specify patient harm linked to the recalled metoprolol. Experts, however, warn that inconsistent drug dissolution could compromise treatment for cardiovascular conditions. Patients are advised to consult physicians before discontinuing use, though alternatives may be warranted given the potential for subpar efficacy.

As regulatory scrutiny clashes with pharmaceutical cost-cutting pressures, this development renews debates over reliance on overseas manufacturing and the FDA’s capacity to ensure rigorous oversight. With millions of Americans dependent on affordable generics, the balance between access and safety remains precarious. Without structural reforms to both corporate practices and federal monitoring, the tension is unlikely to be resolved.

The FDA encourages healthcare providers to report adverse events through its MedWatch system, while Granules has yet to publicly address the recall beyond regulatory filings. For now, the incident serves as another cautionary footnote in the ongoing struggle to reconcile globalized drug production with uncompromising standards for patient care.

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