FDA daily

FDA daily for Tuesday, May 5, 2026

In this issue: 8 approvals, 1 device recall, 17 device decisions and 115 label changes. 3 items touch categories MedGrid carries, and they come 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 and biologic approvals

FDA date:

On Tue, Apr 28 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 6 supplements to existing ones.

Browse drug and biologic approvals in FDA data →

Device recalls

FDA date:

FDA posted 1 device recall from 1 firm on Tue, Apr 28.

Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 8 510(k)s and 9 PMA decisions on Tue, Apr 21.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

115 drug labels took effect on Tue, Apr 21; 2 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.

  • Broad Spectrum SPF45

    ZINC OXIDE, OCTINOXATE · Drmtlgy, LLC · TOPICAL

    Sunscreen & SPFHUMAN OTC DRUG
  • HYDRA SPF 34

    HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE · Drmtlgy, LLC · TOPICAL

    Sunscreen & SPFHUMAN OTC DRUG
  • Tikosyn

    DOFETILIDE · Pfizer Laboratories Div Pfizer Inc · ORAL

    Boxed warningHUMAN PRESCRIPTION DRUG
  • IRBESARTAN

    IRBESARTAN · Jubilant Cadista Pharmaceuticals Inc. · ORAL

    Boxed warningHUMAN PRESCRIPTION DRUG
  • Morphine Sulfate

    MORPHINE SULFATE · Hospira, Inc. · EPIDURAL, INTRATHECAL +1

    Boxed warningHUMAN PRESCRIPTION DRUG
  • Diclofenac Potassium

    DICLOFENAC POTASSIUM TABLETS · Umedica Laboratories USA Inc. · ORAL

    Boxed warningHUMAN PRESCRIPTION DRUG
  • Hydromorphone Hydrochloride

    HYDROMORPHONE HYDROCHLORIDE · Hospira, Inc. · INTRAMUSCULAR, INTRAVENOUS +1

    Boxed warningHUMAN PRESCRIPTION DRUG
Browse label updates in FDA data →

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.