Contamination Control

Greenwich Rx Recalls Compounded Glutathione for Potential Elevated Endotoxin

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Greenwich Rx, a 503A compounding pharmacy, announced a voluntary nationwide consumer-level recall of ten lots of compounded glutathione injection 200 mg/mL in 10 mL multidose vials because of potential elevated endotoxin levels. The affected product was intended for subcutaneous injection and was distributed to patients from June 26 through September 21, 2026, with beyond-use dates from October 2 through November 12, 2026. The stated risks include fever, hypotension, inflammatory reactions, anaphylactic shock, and death. The company reported that two patients required emergency department care after intravenous administration of a glutathione product not formulated for IV use. Customers were instructed to stop using recalled product and follow disposal directions. The recall is being conducted with FDA’s knowledge.

FDA Cites Sterile Injectable CGMP Violations at Fresenius Kabi Facility

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FDA issued a warning letter to Fresenius Kabi AG after a January 27 to February 18, 2026 inspection identified significant CGMP violations at its Melrose Park sterile injectable facility. FDA cited inadequate investigations of endotoxin and bioburden signals, media fill failures, complaints, and biological particulate contamination; deficient aseptic process simulations and cleanroom practices; and inadequate visual inspection, facility, and equipment controls. The letter states that investigations overrelied on passing finished-product tests and lacked supported root causes, broad scope, and CAPA effectiveness checks. It also describes recalls of three famotidine injection batches and, following FDA discussions, six batches of other injectable products. FDA requested independent assessments, retrospective reviews, remediation plans, and a response within 15 business days.

Par Health Recalls Two Dexmedetomidine Injection Lots for Particulate Matter

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Par Health announced a voluntary nationwide recall to the hospital level of two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 400 mcg/100 mL, after particulate matter was identified as cellulose or stopper material. The affected lots are 87558, expiring February 2027, and 88802, expiring April 2027. They were distributed to wholesalers between May 13 and June 29, 2025. Wholesalers and hospital pharmacies were instructed to stop use and distribution and return existing inventory. The announcement states that particulate administration could cause life-threatening vascular consequences. No related adverse events had been reported.

FDA Warning Letter: Bausch & Lomb cited for aseptic processing and contamination-control deficiencies

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FDA states that its March 12–20, 2026 inspection of Bausch & Lomb’s Tampa drug manufacturing facility identified significant CGMP violations involving sterile prescription and OTC products. Environmental and personnel monitoring did not sufficiently cover significant locations, procedures were inadequate, and cracked media could not adequately support growth of recovered contamination. From 2023 to 2025, the firm routinely recovered out-of-limit microorganisms in ISO 5 areas, including gram-negative organisms associated with water sources, but continued production without adequate CAPA. FDA also cited inadequate investigations of microbiological departures and adverse trends, insufficient microorganism identification, RABS and barrier-design deficiencies, and smoke studies that did not sufficiently demonstrate unidirectional airflow. Operators were repeatedly observed using poor aseptic techniques during filling. Media fills were substantially smaller than commercial batches and did not adequately represent contamination risks; a July 2025 media fill failed with fungal and spore-forming bacterial contamination. FDA further stated that management oversight was ineffective and the quality unit lacked sufficient authority or implementation of its responsibilities.

FDA Warning Letter: Jabil sterile manufacturing deficiencies involving fungal contamination and quality oversight

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FDA’s February 23 to March 6, 2026, inspection of Pharmaceutics International, Inc., a Jabil company and contract manufacturer of sterile injectables, identified significant finished-pharmaceutical CGMP violations. FDA found inadequate investigations of a sterility failure involving Ustilago spermophora and recurring fungal recoveries in Grade A filling areas, including insufficient root-cause analysis, trend evaluation, and CAPA. The quality unit did not ensure complete documentation of aseptic interventions; one batch record documented 12 interventions although records indicated approximately 200 occurred. FDA also cited inadequate disinfectant efficacy studies and failure to perform process validation after adding a production step. Airflow visualization studies were deficient or omitted following RABS modifications, and some interventions lacked adequate smoke visualization. Environmental monitoring used insufficient sampling techniques and locations. Classified areas also had peeling paint and plastic debris. FDA considered the company’s responses inadequate because they did not sufficiently address contamination sources, systemic investigation weaknesses, quality oversight, or sustainable remediation.

FDA Warning Letter: Reliance Life Sciences cited for data integrity and aseptic processing deficiencies

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FDA’s February 19–27, 2026 inspection of Reliance Life Sciences’ Navi Mumbai drug facility identified significant CGMP violations involving laboratory data, sterile manufacturing, and quality oversight. FDA found environmental monitoring and other microbiology samples recorded as collected and incubated even though plates were absent and analysts confirmed the samples were not collected. LIMS calculations omitted required dilution factors, while electronic integrity-testing files lacked unique names and were overwritten; testing was also not performed for one plant. FDA said these deficiencies created a risk of underreported microbial findings and unreliable batch-release evidence. In aseptic operations, investigators observed operators blocking unidirectional airflow over critical locations and not discarding potentially compromised vials. FDA also observed deteriorated or damaged manufacturing areas or components, excess sealant near HEPA filters, nonsterile wipes used for cleaning, and standing water and staining near pipelines. FDA deemed the firm’s responses insufficient, citing incomplete remediation detail, traceability, oversight, and timelines. The company agreed to recall all sterile drugs and suspend U.S.-market production; FDA later placed its drugs on Import Alert 66-40.

FDA Warning Letter: Insanitary API Manufacturing, Incomplete Laboratory Data, and Weak Quality Oversight

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FDA states that its April 13 to 17, 2026 inspection of Shoolin Pharma Chem LLP found APIs prepared, packed, or held under insanitary conditions and identified significant API CGMP violations. Investigators observed layered unidentified residues, chemical residues and stains on walls, floors, equipment, and product-contact areas; corroded or apparently rusted surfaces; leaking lines; improperly stored transfer lines; and an employee wearing open-toed sandals near open equipment during production. Nondedicated equipment was used for multiple APIs. FDA also found inadequate written cleaning and maintenance procedures, no swab or rinse cleaning verification, and insufficient cleaning validation remediation. The firm could not provide raw data supporting certificate-of-analysis results, while contract-laboratory results were reported on company letterhead without identifying the original laboratory. Stability chambers were powered off or outside temperature or humidity conditions, supporting records were unavailable, and tadalafil samples were missing. FDA further cited inadequate quality-unit oversight of impurity risks, contract laboratories, process validation, equipment calibration, materials testing, and annual product reviews. The firm recalled all APIs distributed in the U.S., and FDA placed its drugs on Import Alert 66-40.

FDA Warning Letter: Fresenius cited for leaking dialysis solution bags and inadequate visual inspection controls

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FDA inspected Fresenius USA Manufacturing’s Ogden, Utah drug facility from March 2-6, 2026, and cited significant CGMP violations involving complaint investigations, CAPA, process controls, and visual inspection of sterile injectable products. For Delflex Peritoneal Dialysis Solution, an August 2025 investigation covered 35 complaints involving approximately 156 leaking bags from multiple batches and attributed holes to printing. FDA stated that the firm assigned the lowest severity despite its matrix identifying peritonitis as a potential harm at the highest severity, did not recall then, and inadequately investigated risk and implemented CAPA. After inspection, reexamination found perforations without substantial fluid in the overwrap; the firm reassessed risk and recalled affected lots on April 6, 2026 for lack of assurance of sterility. FDA found the response still lacked sufficient CAPA to improve leak detection. FDA also found personnel qualification for visual particulate inspection inadequate because the kit was not adequately representative and records lacked sufficient detail, and said the response did not demonstrate reliable detection at an appropriate level.

B. Braun Recalls Three Sodium Chloride Injection Lots for Zinc Oxide Particulates

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B. Braun Medical Inc. voluntarily recalled three lots of 0.9% Sodium Chloride Injection USP, 100 mL in 150 mL PAB® containers, nationwide at the hospital, healthcare facility, and user levels. The recall followed detection of particulate matter identified as zinc oxide. Affected lots are J6B435, J6B444, and J6B457, with expiration date 30APR2027; distribution occurred from February 27, 2026 through August 3, 2026. The company warned that intravenous administration could cause life-threatening vascular, immune, organ, or blood-cell effects. No serious injuries, deaths, or other adverse events had been reported. B. Braun is notifying distributors and customers and arranging returns and replacements.

FDA Warning Letter: Suretec Innovations cited for component, microbiological, and quality-unit controls

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FDA states that its March 2–5, 2026, inspection of Suretec Innovations’ Arizona facility found significant CGMP violations in OTC drug manufacturing. The firm did not adequately identity-test incoming components, including the API, and relied on supplier certificates of analysis without establishing their reliability. FDA also found inadequate finished-product microbiological testing: the non-compendial method lacked appropriate incubation times, method suitability, controls, and validation. The quality unit did not thoroughly investigate microbial out-of-limit results from a system supplying a manufacturing component; material from that system continued to be used in products that were released. FDA further found that the quality unit lacked adequate authority and oversight, including for production and process procedures, system qualification, stability testing, defined quality-unit responsibilities, and sufficient qualified personnel. FDA judged the firm’s responses inadequate because they lacked key documentation, implemented investigation controls, and retrospective assessments of distributed product quality. FDA requested material-system and supplier reviews, component and retain-sample testing, investigation remediation, risk assessment, CAPA, and comprehensive quality-unit remediation.