Regulatory Analysis
FDA regulatory intelligence, warning letter breakdowns, and actionable analysis for brands across all FDA-regulated categories.
Weekly FDA Roundup: Hospital Drug Mix-Up, Natural Dye Delays, and a Cancer "Vaccine" Warning — Week of March 21–28, 2026
Amneal Pharmaceuticals recalls magnesium sulfate pouches after a tranexamic acid mix-up reaches hospitals nationwide. FDA delays beetroot red and spirulina extract approvals indefinitely. ImmunityBio warned over "cancer vaccine" claims for bladder cancer drug ANKTIVA. Plus six warning letters, two Class I device recalls, and two rare pediatric drug approvals.
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Weekly FDA Roundup: Higher-Dose Wegovy Fast-Tracked, Device Recalls Report Injuries and a Death, Week of March 14-20, 2026
Higher-dose Wegovy approved in 54 days via the CNPV program. Two device recalls tied to 22 injuries and one death. Made Fresh Salads pulls 14 cream cheese products for Listeria. Plus 11 warning letters.
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Weekly FDA Enforcement Roundup — March 6–13, 2026
13 warning letters. A new draft guidance on 483 responses. 61 drug approvals pulled. The AEMS launch. And Novo Nordisk in the hot seat over unreported GLP-1 deaths.
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FDA Recall List, March 2026: Undeclared Allergens, Hidden Prescription Drugs, and Plastic Contamination
The FDA recall list for late February and early March 2026 shows three clear patterns: an allergen labeling wave, prescription drugs in supplement products, and physical contamination at scale.
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Weekly FDA Roundup: Compounding Crackdown and Device Safety Alerts — Week of Feb 21–28, 2026
55 FDA actions in one week: a landmark framework for ultra-rare genetic disease therapies, a compounding pharmacy warning letter previewing the GLP-1 enforcement surge, four medical device safety alerts from four manufacturers, and two recalls for undeclared prescription drugs in supplements.
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Weekly FDA Roundup: US-EU Pharma Deal Revoked, Blood Glucose Device Death, and 8 Class I Recalls — Week of Feb 14–21, 2026
FDA revokes the US-EU pharmaceutical GMP mutual recognition agreement effective March 23, while a blood glucose correction links 114 injuries and one death to an error-code flaw, and five simultaneous Class I recalls sweep a hummus brand.
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Weekly FDA Roundup: Hormone Therapy Gets a New Label, Botulism Stalks the Supplement Aisle — Week of Feb 7–14, 2026
FDA removed MHT boxed warnings, approved a first-of-its-kind pancreatic cancer device, launched a BHA reassessment, and fielded 51 recalls — including a 12-SKU Clostridium botulinum sea moss gel cluster.
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Weekly FDA Roundup: GLP-1 Crackdown, Abbott's Triple Hit, and the Artificial Colors Pivot — Week of Jan 31–Feb 7, 2026
FDA signals the end of the GLP-1 compounding era, Abbott Diabetes Care faces three enforcement actions in 48 hours, and new artificial color policy clears the path for natural alternatives.
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Weekly FDA Roundup: Flawed Blood Lead Test, FSVP Enforcement Wave, and 22 Recalls — Week of January 26, 2026
FDA's week of Jan 24–31 brought 35 actions: a warning letter targeting a pediatric blood lead testing device with false positives, four FSVP letters in one day, and 22 recalls dominated by allergen and labeling failures.
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Weekly FDA Roundup: MAHA Takes Shape in Policy, 28 Recalls, and a Wound Care Alert — Week of Jan 17–24, 2026
FDA issued a MAHA-driven gluten labeling RFI, reported ImportShield efficiency gains, and posted five warning letters — alongside 28 recalls and a serious wound care device alert from Integra LifeSciences.
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Weekly FDA Roundup: Pecorino Romano Class I Recall Sweep and CGT Flexibility Shift — Week of Jan 10–17, 2026
A coordinated 8-product Class I recall from Ambriola Co. swept multiple Pecorino Romano brands; FDA formalized CMC flexibility for cell and gene therapies under Commissioner Makary.
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Weekly FDA Roundup: Supplement Adulteration, CGMP Cluster, and Nicotine Pouch Crackdown — Week of January 3–10, 2026
FDA opened 2026 with a targeted enforcement week: a dietary supplement recalled for undeclared meloxicam, three CGMP warning letters to OTC manufacturers on the same day, and two tobacco retailers cited for unauthorized nicotine pouches.
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Weekly FDA Roundup: PFAS in Cosmetics, a Children's Supplement Spiked with an Unapproved Drug, and a Holiday Recall Wave — Week of Dec 27–Jan 3
FDA's MoCRA report finds insufficient safety data for most PFAS in cosmetics; a children's growth supplement contained hidden ibutamoren; seven herbal products recalled in one sweep.
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