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Recent WeighedHealth coverage: FDA decisions, recalls, GLP-1 shortage updates, legislation tracking, and editorial deep-dives.
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Recall & safety coverage
All recalls →ProRx LLC recalls compounded semaglutide and tirzepatide (October 2025)
In October 2025, compounder ProRx LLC initiated a voluntary nationwide recall of lots of its compounded semaglutide and tirzepatide injectable products due to lack of sterility assurance identified during inspection. Recalled lots and distribution details are listed in the FDA Enforcement Report database. Non-sterile injectables carry a risk of injection-site and bloodstream infections. Patients with affected lots were instructed to stop use and contact their dispensing pharmacy; no confirmed patient harm had been reported at announcement.
FDA warning letters to GLP-1 compounders and sellers, September 2025
With the tirzepatide shortage declared resolved in December 2024 and the semaglutide shortage in February 2025, the legal basis for routinely compounding "essentially a copy" of those drugs ended. In September 2025 the FDA announced a wave of warning letters to companies that continued compounding GLP-1 products or marketing unapproved GLP-1 drugs — citing violations of compounding rules, sourcing of semaglutide salt forms not permitted for compounding, and misleading marketing claims about equivalence to the approved products. Many recipients discontinued GLP-1 compounding; enforcement against non-compliant sellers has continued into 2026. Individual letters are published in the FDA's warning-letters database.
FDA declares semaglutide injection shortage resolved (February 2025)
On February 21, 2025 the FDA announced its determination that the shortage of semaglutide injection products (Wegovy and Ozempic) was resolved, with Novo Nordisk able to meet current and projected US demand. Because compounding of "essentially a copy" of an FDA-approved drug is only permitted during a shortage, the determination started a wind-down period for compounded semaglutide: 503A compounding pharmacies were given until April 22, 2025 and 503B outsourcing facilities until May 22, 2025 to stop producing it. Telehealth services that had offered compounded semaglutide during the shortage transitioned patients to branded Wegovy/Ozempic or alternative therapies.
FDA alert: counterfeit Ozempic pens found in US supply chain
On December 21, 2023 the FDA alerted patients, pharmacies, and wholesalers that counterfeit Ozempic (semaglutide) 1 mg pens had entered the US drug-supply chain outside authorized channels. The counterfeit products carry lot number NAR0074 with serial number 430834149057. FDA and Novo Nordisk seized thousands of units and advised that the pen needles in the counterfeit kits are themselves counterfeit, so their sterility cannot be assured. FDA reported a small number of adverse-event reports associated with the lot, none serious and consistent with known GI side effects of semaglutide. Wholesalers, pharmacies, and patients were told not to distribute, dispense, or use pens labeled with that lot/serial combination.
Latest articles
All articles →- glp1
CagriSema: the amylin + GLP-1 combo and what REDEFINE actually showed (2026)
CagriSema pairs semaglutide with cagrilintide, an amylin analog — a different mechanism from tirzepatide or retatrutide. Its phase 3 REDEFINE 1 trial showed about 20% average weight loss at 68 weeks. Here's the evidence, how it differs, and its status.
- glp1
GLP-1 drugs and gallstones: the real risk, why it happens, and what to watch (2026)
GLP-1 medications raise the risk of gallbladder and biliary disease — a 76-trial meta-analysis found the risk more than doubled in weight-loss trials. Here's why it happens, the actual numbers, the warning signs, and how to lower your risk.
- glp1
Retatrutide: the triple-agonist obesity drug and its record 24% weight loss (2026)
Retatrutide is an investigational triple-hormone-receptor agonist that produced the largest average weight loss of any obesity drug published to date — about 24% at 48 weeks in its phase 2 trial. Here's what the evidence shows, how it differs from Wegovy and Zepbound, and its actual status.
- glp1
Orforglipron: the once-daily GLP-1 pill and what its phase 3 trial showed (2026)
Orforglipron is an investigational oral GLP-1 drug — a true once-daily pill with no food or water timing rules. Its phase 3 obesity trial showed about 11% average weight loss at 72 weeks. Here's how it compares to injections and to Rybelsus, and where it stands.
- glp1
Peptides for weight loss: what actually works, what's unproven, what's illegal
The only weight-loss peptides with FDA approval and large human trials are the GLP-1 drugs — semaglutide (~15% mean loss in STEP-1) and tirzepatide (~21% in SURMOUNT-1). Most products marketed online as 'weight-loss peptides' (BPC-157, ipamorelin, 'research-grade' retatrutide) have no human efficacy trials, no FDA oversight, and no sterility assurance.
- ed
Rhino pills: why the FDA keeps finding hidden sildenafil in 'natural' ED supplements
Gas-station ED pills marketed as 'natural' (Rhino, and hundreds of similar brands) are repeatedly found by FDA testing to contain undeclared sildenafil or tadalafil — real prescription drugs at unknown doses. That makes them dangerous for anyone on nitrates, and pointless for everyone else: you're taking Viagra's active ingredient without the dosing, screening, or purity control.
- hair_loss
Minoxidil timeline: when it starts working, why shedding happens first
Minoxidil results follow a predictable arc: initial shedding in weeks 2-8 (a sign follicles are cycling, not failing), first visible regrowth around months 2-4, and full assessable effect at 6-12 months. Quitting during the shed — the most common mistake — resets the clock to zero.
- testosterone
Enclomiphene for testosterone: the evidence, and what telehealth ads don't say
Enclomiphene raises testosterone by stimulating your own production — and unlike testosterone replacement, it preserves sperm counts. The part the ads skip: it is not FDA-approved (the Androxal application was not approved in 2015), so every enclomiphene prescription today is off-label compounded medication.
- glp1
Stopping a GLP-1 before surgery: what the anesthesia guidance actually says (2026)
GLP-1 medications slow how fast your stomach empties, which raises the aspiration risk under anesthesia even after normal fasting. Here is what the ASA guidance and the 2024 update say about when to hold your dose — and what changed.
- glp1
Zepbound for sleep apnea: what the FDA approval and SURMOUNT-OSA actually showed (2026)
In December 2024 tirzepatide (Zepbound) became the first drug FDA-approved for obstructive sleep apnea. Here is what the SURMOUNT-OSA trials measured, how much it reduced apnea events, and who the approval is — and isn't — for.
- glp1
Does Ozempic affect birth control? What the GLP-1 labels actually say (2026)
The oral-contraceptive warning belongs to tirzepatide (Mounjaro, Zepbound), not semaglutide. Here is exactly what each FDA label says, why the difference exists, and what to do about backup contraception — in plain terms.
- glp1
Wegovy for heart disease: the SELECT trial and the cardiovascular indication (2026)
In 2024 Wegovy became the first weight-loss drug FDA-approved to cut cardiovascular risk. The basis was SELECT, a 17,604-patient trial that reduced heart attacks, strokes, and CV death by 20%. Here is what it showed and why it changed coverage.
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