The FDA Desk — 2026-04-26

TITLE: FDA Desk — 2026-04-26: Sterility failures dominate as Fresenius Kabi pulls seven saline lots; Fagron vancomycin and Teva clonidine also recalled

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At a Glance

No Class I recalls were posted today. All ten entries are Class II, firm-initiated voluntary recalls, but the cluster is notable: sterility assurance failures across multiple sterile injectable manufacturers, plus a CGMP raw-material deviation hitting two Teva clonidine transdermal SKUs.

Class II — Sterility Assurance Failures

Fresenius Kabi sodium chloride injection (seven lots)

Fresenius Kabi USA (Lake Zurich, IL) initiated a sweeping March 11 recall of sodium chloride injection in freeflex bags across multiple concentrations and fill volumes, all citing "Lack of Assurance of Sterility." The seven affected entries span the company's standard saline portfolio:

• D-0426-2026, D-0427-2026, D-0428-2026, D-0432-2026 — 0.9% Sodium Chloride Injection, USP in 100 mL, 250 mL, and 500 mL freeflex bag presentations (NDCs 65219-468, -470, -472, -432) distributed Rx-only by Fresenius Kabi.
• D-0430-2026 — 0.9% Sodium Chloride Injection 100 mL Single Dose freeflex bag manufactured by Fresenius Kabi but distributed under the BD (Becton, Dickinson) label out of Franklin Lakes, NJ, extending the recall's footprint into BD's customer base.
• D-0424-2026 — 0.45% Sodium Chloride Injection, USP, 250 mL freeflex bag (NDC 63323-626-03), the lone half-normal saline SKU in the cluster.

Given saline's role as a vehicle for countless IV admixtures, hospital pharmacy and infusion-center inventories should be scrubbed against these NDCs immediately; a sterility-assurance failure in a diluent propagates risk to every downstream compounded dose.

Fagron Sterile Services — Vancomycin admixtures

• D-0440-2026 and D-0441-2026 — Fagron Compounding Services (Wichita, KS) recalled compounded Vancomycin HCl 1.25 g and 1.5 g in 250 mL 0.9% Sodium Chloride Injection USP (NDCs 71266-5083-01 and 71266-5085-01) on March 20 for both lack of sterility assurance and a device defect: the blue Break-Off-Part on the administration port could detach, presenting a contamination and dosing-integrity risk on top of the underlying sterility concern.

Class II — CGMP Deviations

Teva / Actavis clonidine transdermal systems

• D-0472-2026 and D-0473-2026 — Teva Pharmaceuticals USA recalled Clonidine Transdermal System, USP at the 0.1 mg/day and 0.2 mg/day strengths (manufactured by Actavis Laboratories UT, distributed by Actavis Pharma) on March 19 for CGMP deviations involving the use of an unapproved raw material. Because clonidine TTS is widely used for hypertension and off-label for ADHD and opioid-withdrawal management, prescribers should anticipate substitution requests; the raw-material deviation, while not a sterility issue, raises identity and quality questions across affected lots.

Editorial Note

The Fresenius Kabi action — seven separate recall numbers issued on a single day for the same root cause across the saline line — suggests a process- or facility-level sterility finding rather than isolated lot deviations. Health systems carrying BD-labeled saline (D-0430-2026) should note the manufacturing relationship, since the BD trade dress can mask the Fresenius Kabi origin during inventory checks.