Macleods Pharma olmesartan medoxomil recall: affected products, why it happened, and what to do
A nationwide recall of a generic triple-action blood pressure medication has been issued after dissolution testing showed the tablets may not dissolve as required. The recall involves Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets manufactured by Macleods Pharma USA and distributed across the United States. The key details below help identify whether your bottle is affected, what the failure means for safety, and the steps you should take.
At a glance: two recalled lots cover a total of 3,528 bottles of the 30-count size (Lot 12251163A, NDC 33342-246-07, exp 05/31/2027) and 216 bottles of the 90-count size (Lot 12251163B, NDC 33342-246-10, exp 05/31/2027). The recall reason is “failed dissolution specifications.” This is classified as a Class II recall, meaning use may cause temporary or medically reversible adverse health consequences, with remote likelihood of serious harm. The recall began Oct. 7 (Macleods initiated) and was classified by the FDA on Oct. 26, with nationwide distribution affected. The FDA enforcement report provides the formal recall record and is the official source for the action.
Affected products
The recall applies to two bottle configurations of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets (40 mg/10 mg/12.5 mg). The 30-count bottles carry NDC 33342-246-07, Lot 12251163A, expiring 05/31/2027, with 3,528 bottles affected. The 90-count bottles carry NDC 33342-246-10, Lot 12251163B, expiring 05/31/2027, with 216 bottles affected. Consumers can locate the NDC, lot number, and expiration date on the printed label of each bottle. The official FDA enforcement report documents these specifics and the action taken.
Why this recall happened
The FDA lists the recall reason as “failed dissolution specifications,” meaning the tablets did not dissolve properly during testing. This quality issue can affect the product’s potency and effectiveness, which is why the action was taken and distributed nationwide.
Timeline and regulatory context
Macleods Pharma USA initiated the recall on October 7. The FDA classified it on October 26, labeling it a Class II recall. The recall remains active and nationwide as part of ongoing regulatory action. In a related regulatory context, a separate recall of chlorthalidone tablets by Inventia Healthcare Ltd. occurred weeks earlier due to a similar dissolution issue, illustrating that dissolution failures have been a broader quality concern in recent weeks.
Regulatory context and manufacturer history
For readers evaluating the manufacturer’s quality history, it is relevant to note that Macleods Pharma was involved in a 2019 Losartan recall due to impurities traced to APIs manufactured by Hetero Labs Limited. This context helps readers assess whether dissolution problems are isolated to a single product and batch or reflect broader quality-control patterns. The 2019 Losartan recall is documented in reporting on the topic and provides a historical perspective on the company’s regulatory history.
What the FDA says about consumer instructions
For Class II recalls, the FDA guidance is that you “can generally continue taking the medicine unless the recalling company provides other instructions.” This phrasing is drawn from FDA guidance on Understanding Drug Recalls. It is important to rely on official FDA statements for patient-specific directions and updates, rather than assuming a new instruction is issued for every recall. Understand Drug Recalls provides the exact framework for Class II recalls and consumer actions.
What to do with a recalled bottle
As the recall progresses, the FDA has not issued specific consumer instructions beyond advising patients to consult their prescribers. If you have any recalled medication at home, you should contact the doctor who prescribed it before discontinuing use. If you’ve been taking the recalled pills and have health concerns, speak with your doctor promptly. As of the recall announcement, the FDA has not issued specific consumer instructions for returning or disposing of the product.
How to verify if your bottle is affected
First, confirm the bottle’s identification: check the National Drug Code (NDC) and the lot number printed on the label. For the recalled lots, look for NDC 33342-246-07 on the 30-count bottles with Lot 12251163A and expiration 05/31/2027, or NDC 33342-246-10 on the 90-count bottles with Lot 12251163B and expiration 05/31/2027. If your bottle matches these details, contact your prescriber before taking any action. Additionally, verify the expiration date; both recalled lots expire on May 31, 2027. For readers seeking primary documentation, the FDA enforcement report No. 100113 offers the official record of the recall, and the FDA’s Recalls, Market Withdrawals, & Safety Alerts page provides ongoing updates.
When possible, consult your pharmacist or healthcare provider to discuss alternatives or a plan for your blood pressure management while the recall is in effect.
Official sources and updates
Stay informed through the U.S. Food and Drug Administration (FDA). The enforcement report (No. 100113) documents the recall details, and the FDA’s Recalls, Market Withdrawals, & Safety Alerts page aggregates current recall information. For quick verification, you can also consult Everyday Health’s coverage, which references the FDA guidance on Class II recalls. Always prioritize official FDA communications for the most authoritative guidance.
Key sources include: Enforcement Report No. 100113 (FDA) and FDA Recalls, Market Withdrawals, & Safety Alerts page. FDA enforcement reports and FDA Recalls page.
Notes for readers
Readers are encouraged to monitor official FDA updates for any changes in the status of this recall. If you have questions about your prescription, contact your pharmacist or healthcare provider. This article preserves all product details, dates, and instructions as provided by FDA sources and contemporaneous reporting, and presents them in a way that clarifies what affected patients need to know and do.
Sources
References and notes include the FDA Enforcement Report No. 100113, FDA guidance on Understanding Drug Recalls, and contemporaneous reporting from Everyday Health and related outlets documenting the recall specifics, NDCs, lot numbers, and expiration dates. Links provided above connect to official FDA pages for verification.