FDA daily

FDA daily for Friday, September 11, 2026

In this issue: 1 shortage update, 6 approvals, 12 device recalls, 29 device decisions and 136 label changes. 1 item touches categories MedGrid carries, and it comes first.

For MedGrid's categories

Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.

Drug shortages

FDA date:

FDA updated 1 shortage entry on Thu, Sep 10: 1 new, 1 to be discontinued.

Browse drug shortages in FDA data →

Drug and biologic approvals

FDA date:

On Fri, Sep 4 FDA approved 2 new applications (1 brand or biologic, 1 generic) and 4 supplements to existing ones.

Browse drug and biologic approvals in FDA data →

Device recalls

FDA date:

FDA posted 12 device recalls from 5 firms on Fri, Sep 4.

Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 16 510(k)s and 13 PMA decisions on Fri, Aug 28.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

136 drug labels took effect on Fri, Aug 28. Below: those, and labels carrying a boxed warning.

  • Ketorolac Tromethamine

    KETOROLAC TROMETHAMINE · REMEDYREPACK INC. · ORAL

    Boxed warningHUMAN PRESCRIPTION DRUG
  • etodolac

    ETODOLAC · A-S Medication Solutions · ORAL

    Boxed warningHUMAN PRESCRIPTION DRUG
Browse label updates in FDA data →

FDA did not answer for Food and supplement recalls, Drug recalls while this issue was written; those sections will fill in on a later visit.

How the FDA daily is written

Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.