FDA daily for Wednesday, July 29, 2026
In this issue: 14 drug recalls. 2 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.
- LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70…
Bell Pharmaceuticals, Inc · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.)…
Bell Pharmaceuticals, Inc · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Drug recalls
FDA date:FDA's enforcement report dated Wed, Jul 22 lists 14 drug recalls: 14 Class II.
- LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70…
Bell Pharmaceuticals, Inc · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.)…
Bell Pharmaceuticals, Inc · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Car…
Chiesi USA, Inc. · Lack of Assurance of Sterility
- QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16)…
Bell Pharmaceuticals, Inc · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Car…
Bell Pharmaceuticals, Inc · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS…
Bell Pharmaceuticals, Inc · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) e…
CareFusion 213, LLC · Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
- CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.
Bell Pharmaceuticals, Inc · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-…
Padagis US LLC · Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
- meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPID…
Bell Pharmaceuticals, Inc · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800…
Bell Pharmaceuticals, Inc · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-8…
Bell Pharmaceuticals, Inc · SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA did not answer for Food and supplement recalls, Clearances, Device recalls, Drug shortages, Approvals, Labels 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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