Recent FDA Recall Highlights & Developments -

• The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the use, content and circumstances for issuance of public warning and public notifications for recalls.

• FDA finalized Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff, providing answers to common questions regarding the agency’s mandatory food recall authority.

• The agency gained the authority to issue a mandatory recall order for controlled substances under circumstances involving a reasonable probability of serious adverse health consequences or death.

• FDA increased recall information dissemination via social media, announcing a multi-state Salmonella outbreak on Twitter and Facebook.

• The agency issued its first mandatory food order of a food product under the agency’s recall authority, which required the removal of Salmonella-contaminated kratom products from the market.