Macleods Pharma USA is recalling 3,744 bottles of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets nationwide after the pills failed dissolution specifications. The FDA classified it as Class II, and people should check with a doctor or pharmacist before changing use.
Macleods Pharma USA, Inc. is recalling 3,744 bottles of olmesartan medoxomil/amlodipine/hydrochlorothiazide blood pressure medication nationwide over failed dissolution specifications. Macleods Pharmaceuticals first recalled the tablets on Oct. 7. The pills were available across the US, and the manufacturer issued the recall voluntarily via the FDA.
The FDA listed the reason as failed dissolution specifications, meaning the pills did not dissolve as required during testing. The drug does not release its active ingredients at a proper rate inside the body. The three-in-one pill contains olmesartan, amlodipine and hydrochlorothiazide, and the failed tests could mean it is not absorbed by the body as intended.
Affected lots and quantities
The recalled product is Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets in a 40 mg/10 mg/12.5 mg strength. The 30-count bottles carry NDC 33342-246-07 and lot 12251163A, with an expiration of 05/31/2027. The 90-count bottles carry NDC 33342-246-10 and lot 12251163B, also expiring 05/31/2027. The recall covers 3,528 of the 30-count bottles and 216 of the 90-count bottles. More than 3,700 bottles of blood pressure pills have been recalled nationwide.
What the Class II designation means
The FDA classified the action as a Class II recall. Under that class, use of the affected medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious health consequences is considered remote. For drugs, a Class II recall generally means consumers can continue using the medicine unless the recalling company or FDA advises otherwise. Macleods Pharma has not issued a press release or specific consumer instructions regarding the recall. The FDA notes people can generally continue taking medications affected by Class II recalls, but should check with a doctor or pharmacist first.
