Understood. I’ll look into the potential contamination risks of Brilloez from Sun Pharma, including heavy metals, microbial, solvent, and other impurities. I’ll also check for any relevant regulatory reports, recalls, or third-party lab findings, both in the U.S. and globally.
I’ll let you know as soon as I’ve gathered the findings.
Brilloez Overview
Brilloez (sometimes written “Brillo EZ”) is a generic combination of bempedoic acid (180 mg) and ezetimibe (10 mg) tablets marketed by Sun Pharmaceutical. It appears not to be an FDA-approved product in the U.S. (the FDA-approved branded version of this combo is Nexlizet). We found no direct reports or recalls specifically involving Brilloez. In other words, there is no published evidence of Brilloez batches being contaminated or withdrawn. However, assessing its contamination risk requires examining related products, Sun Pharma’s manufacturing record, and regulatory actions.
U.S. Recalls & Reports (Sun Pharma/Sun USA)
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Febuxostat (gout drug) – In Jan 2024 Sun USA issued a Class II recall of ~55,272 bottles of febuxostat 40 mg/80 mg, after a microbial contamination (stagnant water in equipment duct) was found in the Dadra, India manufacturing plant.
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Methylphenidate HCl (Concerta generic, 20 mg) – On July 24, 2023 Sun USA voluntarily recalled one lot (NDC 57664-230-88) of methylphenidate 20 mg tablets after a piece of metal was found embedded in a tablet. This Class II recall (USA) was due to foreign metal contamination.
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Metformin XR suspension (Riomet ER) – In Sept 2020 Sun USA recalled one lot of Riomet ER (metformin 500 mg/5 mL suspension) because testing found NDMA (a nitrosamine impurity) above FDA’s acceptable intake limit. This was a Class II recall.
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Gabapentin capsules – In Apr 2025 Nigeria’s NAFDAC noted that Sun USA’s affiliate initiated a Class III recall (≈13,700 bottles) of gabapentin 300 mg capsules due to “cross-contamination risks”. (Class III recalls indicate low risk to health, but they reflect manufacturing lapses.)
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Nexlizet (bempedoic acid/ezetimibe) – dissolution failure – Esperion (the U.S. NDA holder for Nexlizet) voluntarily recalled all lots of Nexlizet (180/10 mg) on Sept 6, 2023 after stability testing showed out-of-specification dissolution (bempedoic acid dissolution below spec at 12 months). (If a Sun Pharma generic of this combo were marketed in the U.S., similar issues could plausibly occur, but no Sun Pharma recall on this product is reported.)
These recalls illustrate that Sun/Sun USA products have been withdrawn for microbial contamination (Febuxostat), embedded metal (Concerta generic), residual NDMA (metformin), cross-contamination (gabapentin), and dissolution failure (Nexlizet). While none of these involve Brilloez directly, they show Sun’s U.S. products have faced contamination-related recalls.
Global Recalls and Regulatory Alerts
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India (CDSCO quality alerts) – In Sep 2024 India’s CDSCO flagged 53 drug samples for “quality failures.” Several Sun Pharma products (e.g. Pantocid® pantoprazole, Pulmosil® isosorbide mononitrate injection, Ursocol® ursodeoxycholic acid) were declared “adulterated”. Sun disputed those findings as pertaining to counterfeit batches. While these are not Brilloez, they indicate recent manufacturing/quality scrutiny of Sun products in India.
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Nigeria (NAFDAC) – A Nigerian alert (Apr 2025) noted that leading Indian firms (Sun, Glenmark, Zydus) recalled multiple drugs in the U.S. over CGMP deviations. Sun’s recall (USA) of gabapentin (cross-contamination, Class III) was specifically noted. (NAFDAC did not mention Brilloez.)
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United Kingdom (MHRA recall) – On Mar 4, 2025 the UK MHRA announced a Class 2 recall of Sun Pharma Europe’s pemetrexed infusions (1000 mg and 800 mg bags) due to particulate matter found on stability testing. This was a precautionary recall for out-of-spec particulate impurity (no direct patient harm reported). Again, not Brilloez, but another example of Sun Pharma having to recall for impurity issues in Europe.
Manufacturing/Inspection Findings (Sun Pharma)
Recent FDA inspections of Sun Pharma plants have uncovered serious quality problems that raise general contamination concerns:
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Halol, India (sterile injectable facility) – A June 2025 FDA inspection report (released by ProPublica) found repeated contamination-control failures. Inspectors noted that aseptic procedures were not followed and some equipment was malfunctioning, leading to drugs contaminated with metal particles and “black particles” in vials. Workers were seen contaminating sterile gowns (e.g. touching waste bins then sterile materials), liquid was dripping through ceiling cracks, and fungus/mold grew in testing sample storage. (This Halol plant had been banned from U.S. imports in 2022 but FDA allowed certain “exempted” drugs from it into the U.S. supply chain.)
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Gujarat, India (oral/sterile products) – FDA inspections in June 2025 also cited Sun’s Gujarat plant (same complex as Halol) for “microbiological contamination” risks. FDA observed “poor aseptic behavior” (e.g. gown/glove violations) and found a stability chamber leaking a dark, moldy liquid. Sun’s earlier 2022 warning letter similarly noted inadequate gowning and environmental monitoring at this facility. These findings imply that Sun’s processes at Gujarat/Halol have repeatedly fallen short of preventing microbial contamination.
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Aseptic Production (Block shifts) – A Sun FDA warning letter (Oct 2023) for another Indian plant detailed multiple failures in sterile operations. The FDA found the ISO-5 cleanroom was “poorly designed” (no physical barriers during dispensing) and noted non-unidirectional airflow and operator proximity to sterile product. In summary, FDA cited lack of controls to “prevent contamination” of sterile drugs. Though focused on injectables, this indicates systemic aseptic-process issues.
In sum, FDA inspection reports and investigative journalism (ProPublica, Fierce Pharma) reveal Sun Pharma plants with serious contamination control breakdowns. While these reports involve other products (injectables, etc.), they signal the potential for microbial or particulate impurities if controls are weak.
Potential Contaminant Types
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Heavy Metals: We found no published reports of heavy metal content (like lead, mercury, cadmium) in any Sun Pharma tablets. The closest relevant events were physical metal contamination incidents (e.g. a metal shard in a methylphenidate tablet, or metal shavings on equipment). Those point to foreign object hazards, not residual heavy metals in APIs. No tests were found for Brilloez itself. In general, bulk active ingredients can contain trace metals if synthesis or packaging is impure, but we found no evidence of heavy-metal recalls or alerts for Sun’s lipid-lowering drugs. Nonetheless, given reports of metal particles in unrelated Sun products, there is a conceivable (but speculative) risk that inadequate cleaning could introduce metal particulate contaminants.
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Microbial Contamination: As a solid oral tablet, Brilloez is not sterile; but bacterial or fungal contamination (from water, air, or staff) could theoretically occur if manufacturing is unhygienic. The febuxostat recall shows such contamination can happen in oral medications. The Gujarat/Halol inspection reports detailed fungal growth and poor sanitation. If Brilloez tablets were made at a plant with similar lapses, microbial overgrowth or endotoxins could be a concern. However, no Brilloez lot has been identified as tainted, and shelf-stable tablets typically include preservatives and are less prone than steriles to biologic growth.
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Residual Solvents/Nitrosamines: No specific recalls for residual solvents have been reported by Sun Pharma recently. The NDMA recall (metformin) and a Zydus chlorpromazine recall (nitrosamine impurity) highlight nitrosamine risks in some syntheses. Bempedoic acid’s synthesis involves organic solvents and catalysts, so improper process control could theoretically leave solvent traces or generate nitrosamines. We found no public data on such impurities in Sun’s bempedoic acid/ezetimibe. (Note: the Indian brand Nustendi/Nexlizet in Europe is marketed by Daiichi Sankyo, not Sun, and has no known recalls.)
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Other Impurities: Stability degradants or cross-product contamination can occur. Recall of gabapentin (cross-contamination) and particulate findings in Pemetrexed show impurities/adulterants have surfaced in Sun’s drugs. For Brilloez, degradation products would be assessed during stability testing, but no instability issues are public. Again, nothing specific to Brilloez is reported.
Third-Party Testing & Investigations
We found no published independent lab analyses or consumer-site reports for Brilloez itself. Valisure, Labdoor, and similar groups have tested many generics for NDMA/heavy metals (notably metformin, ranitidine, etc.), but no test results for any bempedoic-acid product were located. A Rapamycin News forum raised concerns about “lead and heavy metals” in Brilloez, but this appears anecdotal. In the absence of lab data, we rely on regulatory findings and recalls as described above.
Investigative journalism has highlighted Sun’s generic quality issues. ProPublica (June/July 2025) obtained FDA inspection records showing Hallol’s contamination. Fierce Pharma also reported FDA observations of moldy liquids in ceilings and gowning lapses. These are independent validations of Sun’s manufacturing problems, but none target the bempedoic acid/ezetimibe line specifically.
Summary – Contamination Risk for Brilloez
No recall or test data indicates that Brilloez is contaminated. However, Sun Pharma’s recent quality-control record is spotty: multiple products have been recalled for impurities or contamination, and FDA inspections have repeatedly cited Sun plants for poor microbiological and particulate controls. In light of this, potential contamination (whether heavy metals, microbes, solvents, or other impurities) cannot be categorically ruled out. Consumers and clinicians should note:
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No known incidents of Brilloez contamination have been publicized. We found no FDA, WHO, or company alert concerning Brilloez batches.
- Sun’s broader recalls (Febuxostat – microbial, Methylphenidate – metal, Metformin – NDMA, etc.) and inspection failures (Halol sterility lapses) suggest vulnerabilities in their quality systems.
- Given these issues, the likelihood of Brilloez contamination appears low by direct evidence, but not negligible in principle. Patients worried about impurities might consider independent testing or using products from manufacturers with cleaner records.
In conclusion, while we found no direct proof of contaminants in Brilloez, Sun Pharma’s history of GMP violations and recalls means a risk remains that any of its products (including Brilloez) could be affected by similar issues. Consumers should stay informed via FDA/health alerts and report any adverse findings, but at present there is no specific contamination alert for Brilloez.
Sources: FDA enforcement reports and recalls; investigative journalism; government alerts; CDSCO/NDTV news. All are authoritative citations as noted.
