FDA´s Enforcement Report - Recent Recalls

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Since July 2018, the FDA´s Enforcement Report weekly tracks and displays updates to a recall’s classification, reason for recall, code information, and product description if changes occur after initial publication.

What is FDA´s Enforcement Report?

In the FDA´s Enforcement Report all recalls monitored by the authority are included once they are classified. They may be listed prior to classification when the FDA determines the company’s removal or correction of a marketed product meets the definition of a recall. Once the FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification.

How are recalls classified?

The FDA classifies a particular product recall to indicate the relative degree of health hazard (class I, II, or III) presented by the product being recalled. Recalls are categorized in the agency´s Enforcement Report as either class I, II, or III or "not yet classified."

Recent recalls

FDA´s recall reports for July 2019 lists several Class II recalls due to various cGMP deviations including

• the ongoing problem of NMBA (N-Nitroso-N-methyl-4-aminobutyric acid) contamination from the losartan API used in the recalled products (tablets),
• possible cross contamination of product due to cleaning procedure failure (tablets),
• lack of assurance of sterility (eye drops, injections),
• failed dissolution specifications (tablets),
• insufficient quality assurance controls over critical systems in the manufacturing facility (ophthalmic ointment),
• OOS results for microbial contamination of non-sterile products / content uniformity (oral suspension / cream),
• products manufactured with lack of process validation, cleaning validation, stability studies, and other cGMP violations (topical creams & gels, including topical CBD creams).

Class III recalls in July 2019 were due to

• product complaints reporting missing bottle label (ophthalmic solution),
• presence of foreign tablet / capsule (tablets).

Two of the recalls on the July 2019 listings have been categorized as Class I (serious health risk). Both of these were injectables:

• one resulted from the finding of glass particulates (presence of particulate matter),
• and the other involved a product labeled as sulfite free that was made from a raw material containing sulfite.

For more information about FDA-regulated products recalls, you can visit Recalls, Market Withdrawals, & Safety Alerts.