Brandywine theophylline tablets recalled in US after gap in shelf-life studies at outside lab

The US Food and Drug Administration has added a recall of Brandywine Pharmaceuticals, LLC's extended-release theophylline tablets to its enforcement report dated 4 November 2026. It is filed as D-0111-2027 and is still open.

The agency attributes the action to a manufacturing-quality deviation under current good manufacturing practice. According to the entry, a continuing study that tracks how the product holds up over time was interrupted. An outside laboratory was running that study for Brandywine.

The commercial impact cannot be assessed from the information available. The record gives no lot numbers, unit quantities, expiry dates or initiation date for the recall, and no sales figures. It also does not say how long the interruption lasted, which batches or time points were affected, or whether any result fell outside specification. The product was distributed across the US.

The FDA places the recall in its second-lowest severity tier. As general context, the agency uses that tier where exposure to a product may cause temporary or medically reversible harm, or where serious harm is considered unlikely.