Baxter CARDENE IV Recall Due to CGMP Deviations
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Baxter Healthcare Corporation is recalling two lots of CARDENE IV due to CGMP deviations.
Reading this FDA recall beyond the headline
This notice was issued by FDA on September 14, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "CGMP Deviations", distributed us nationwide; puerto rico; and chile.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Baxter Healthcare Corporation initiated a voluntary recall of CARDENE IV (Nicardipine Hydrochloride) due to CGMP deviations.
Which Products Are Affected
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, NDC 43066-016-10. Affected lots are Lot # NC177818 (Exp Date: 12/31/2026) and Lot # NC188869 (Exp Date: 12/31/2027). Distributed nationwide in the US, Puerto Rico, and Chile.
What You Should Do
Consumers should contact Baxter Healthcare Corporation for return or refund instructions using the information provided in the recall notification.
Why This Matters
This Class II recall affects prescription intravenous medication distributed across the United States and internationally.
Source
FDA recall number D-0813-2026
Original source: FDA Official Notice ↗
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Elsewhere in the country: similar length or severity timing 8
Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (840 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 14, 2026.
Questions & Answers
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