Over 13,000 bottles of 25 mg chlorthalidone tablets have been recalled due to failed dissolution testing, marking the second such recall for the manufacturer this year.

The FDA has announced a Class II recall of 13,567 bottles of 25 mg chlorthalidone tablets, a diuretic used to treat high blood pressure. This action follows a previous recall in June, bringing the total number of affected bottles to 25,027. Both recalls were initiated due to the medication failing to meet required dissolution specifications.

Recall Details and Safety

The recalled tablets are light yellow, round, and flat, featuring the stamp "103" on one side. All three batches involved in the two recalls share an expiration date of April 2027. A Class II recall indicates that while the medication may cause temporary health issues, the likelihood of serious harm is considered low. According to the FDA, patients should contact their pharmacy to verify if their specific prescription is affected and to discuss potential replacements. The agency advises against stopping medication without professional guidance, as doing so can sometimes be more harmful than continuing to take the recalled product.

Reasons for the Recall

The recalls were prompted by failures in dissolution testing, which measures how quickly a tablet releases its active ingredient into the body. If a tablet does not dissolve at the expected rate, the medication may not be absorbed properly, potentially reducing its effectiveness in treating high blood pressure. While the September enforcement report did not specify the exact failure metrics, a previous notice from distributor Rising Pharma Holdings regarding the June recall noted that some tablets contained 91.5% of the labeled amount, falling just below the 92% minimum requirement. Additionally, some samples showed a 78% dissolution rate, failing to meet the 80% standard.