What is the labetalol and IV cardiovascular supply picture right now?
FDA's drug shortage database has no current shortage record for labetalol, amiodarone or nicardipine, based on openFDA data last updated Oct. 30. Its one related entry is a single diltiazem presentation listed as To Be Discontinued. Absence from FDA's list does not prove normal supply. Named manufacturers report constraints on named NDCs, and availability across the whole market remains unverified.
Labetalol
Baxter's Oct. 23 supply report lists its 100 mg/20 mL vial (NDC 36000-0322-01) as Stocked Out, with a reason code of Demand Increase, next release in late November and recovery in Q1 2027. Pfizer's Oct. 29 availability report lists its 100 mg/20 mL vial (NDC 00409-0125-25) as Limited Supply, with next delivery in February 2027 and recovery in 1Q 2027. Pfizer gives no reason and notes that inventory may not cover market demand.
Baxter's recovery estimate for that vial has moved repeatedly: Q3 2026 in its May 8 report, late November in its Aug. 28 report, and Q1 2027 now.
Amiodarone and Nexterone
Baxter's Oct. 23 report lists Nexterone 360 mg/200 mL (NDC 43066-0360-20) as Limited Supply, with a reason code of Manufacturing Delay, next release in early November and recovery in late November. The 150 mg/100 mL bag (NDC 43066-0150-10) is Supply Available. Fresenius Kabi's Oct. 23 sheet lists its amiodarone vials as Available and warns that it may not be up to date.
The 360 mg status has changed often. Baxter showed it available on allocation on Aug. 28, limited on Sept. 25, available on Oct. 2, and limited again on Oct. 9. Its recovery estimate moved from early October to late November.
The August Nexterone recall is a separate issue
Baxter's recall letter dated Aug. 6 covers several premixed products, including 18 lots of Nexterone 360 mg/200 mL, for potential contamination with a beta-lactam drug product. The letter says affected lots were distributed from Feb. 3, 2025 to July 29, 2026. Baxter said it had not confirmed contamination in distributed non-beta-lactam product and had no related adverse event reports. FDA classified the recall as Class II on Aug. 28 (D-0814-2026, reason CGMP Deviations) and listed it as ongoing in enforcement data last updated Oct. 21.
Baxter's supply report does not cite the recall as a reason for the limited status, and no public source connects the two.
Nicardipine
FDA and the manufacturer reports cited here show no current shortage. Baxter's Oct. 23 report lists all three Cardene presentations as Supply Available, and Fresenius Kabi lists its vial as Available. That includes Baxter's the 40 mg/200 mL bag (NDC 43066-0016-10), which was stocked out on Jan. 23 and limited on July 10. The open items are recalls: two Cardene 40 mg lots in the Aug. 6 action, and one American Regent lot of Civica-labeled vials (25295N0C0) for particulate matter. No source says either recall caused a shortage.
Diltiazem
FDA's only diltiazem entry is the Hospira ADD-Vantage vial (NDC 00409-4350-03), listed as To Be Discontinued. This update found no FDA or manufacturer status for other diltiazem suppliers.
PRN has also seen increased requests for labetalol and other IV cardiovascular products this year.
Are these drugs discontinued, or just difficult to source?
For labetalol and amiodarone, neither FDA nor the manufacturer reports cited here describe a discontinuation. The constrained presentations still carry release or recovery dates. One open question is Pfizer's labetalol 200 mg/40 mL vial, which an undated product page shows as Depleted while the NDC does not appear in the Oct. 29 report.
Diltiazem ADD-Vantage is the one discontinuation in FDA's records for this group, and it covers one NDC. FDA posted it as To Be Discontinued on Jan. 5. Pfizer's undated product page shows it as Depleted, so buyers should not plan around its return. FDA's NDC directory shows a marketing end date of Dec. 31, 2026, a listing field and not a confirmed last-ship date.
What is causing it?
The stated reasons are short manufacturer codes. The underlying causes are not public.
- Baxter labetalol. Demand Increase for 100 mg/20 mL and Third-Party Supplier Issue for 20 mg/4 mL. Baxter does not say what is driving demand or who the supplier is. Pfizer gives no reason.
- Nexterone 360 mg/200 mL. Manufacturing Delay on Oct. 23, Demand Increase on Sept. 25 and Oct. 9, and Manufacturing Delay in January and May. What is delaying manufacture is not public.
- Diltiazem ADD-Vantage. FDA's record describes discontinuation of manufacture. Why the product is being discontinued is not public.
Other Baxter news should not be read as an explanation. FDA issued a warning letter dated Sept. 29 to Baxter's Round Lake, Illinois site. On its Oct. 29 call, according to a third-party transcript, management described manufacturing challenges at Round Lake and supply challenges, now improving, at an unnamed contract manufacturer in its injectables business.
None of those statements names labetalol, Nexterone or Cardene. Baxter and FDA have not publicly linked the letter to the recall or to these statuses, and public sources do not establish where Nexterone or Cardene are made. Baxter's comment on that call that ending cephalosporin production at Round Lake should not cause a market shortage covers cephalosporins only.
Inference, not a manufacturer statement: two manufacturers showing 2027 recovery on the same labetalol vial size suggests planning for that presentation in months, not weeks. It does not establish a common cause.
Which products and presentations are affected?
Status below is by NDC. Baxter's most recent report available for this update is Oct. 23.
| Product | NDC | Manufacturer | Status as of date |
|---|---|---|---|
| Labetalol 100 mg/20 mL vial | NDC 36000-0322-01 | Baxter | Stocked Out; Demand Increase; next release late November; recovery Q1 2027 (Oct. 23) |
| Labetalol 100 mg/20 mL vial | NDC 00409-0125-25 | Pfizer (Hospira) | Limited Supply; next delivery February 2027; recovery 1Q 2027; no reason given (Oct. 29) |
| Labetalol 20 mg/4 mL vial | NDC 36000-0320-01 | Baxter | Supply Available, with Third-Party Supplier Issue; next release late November; recovery Q2 2027 (Oct. 23) |
| Labetalol 20 mg/4 mL Carpuject | NDC 00409-2339-34 | Pfizer (Hospira) | Supply Available (Oct. 29) |
| Labetalol 200 mg/40 mL vial | NDC 36000-0324-01 | Baxter | Supply Available (Oct. 23) |
| Labetalol 200 mg/40 mL vial | NDC 00409-2267-54 | Pfizer (Hospira) | Depleted on an undated product page; not found in the Oct. 29 report. Confirm with Pfizer. |
| Nexterone 360 mg/200 mL Galaxy bag | NDC 43066-0360-20 | Baxter | Limited Supply; Manufacturing Delay; next release early November; recovery late November (Oct. 23). Separately, 18 lots under the Aug. 6 recall. |
| Nexterone 150 mg/100 mL Galaxy bag | NDC 43066-0150-10 | Baxter | Supply Available; no lots in the Aug. 6 recall (Oct. 23) |
| Amiodarone 150 mg/3 mL vial | NDC 63323-0616-03 | Fresenius Kabi | Available; check wholesaler for inventory (Oct. 23) |
| Amiodarone 450 mg/9 mL vial | NDC 63323-0616-09 | Fresenius Kabi | Available; check wholesaler for inventory (Oct. 23) |
| Cardene I.V. 20 mg/200 mL Galaxy bag | NDC 43066-0009-10 | Baxter | Supply Available (Oct. 23) |
| Cardene I.V. 40 mg/200 mL Galaxy bag | NDC 43066-0016-10 | Baxter | Supply Available (Oct. 23). Separately, 2 lots under the Aug. 6 recall. |
| Cardene IV 25 mg/10 mL vial | NDC 43066-0029-10 | Baxter | Supply Available (Oct. 23) |
| Nicardipine 25 mg/10 mL vial | NDC 65219-0818-13 | Fresenius Kabi | Available (Oct. 23) |
| Nicardipine 25 mg/10 mL vial, Civica label | NDC 72572-0470-01 | American Regent for Civica | Lot 25295N0C0 under Class II recall, ongoing (FDA data updated Oct. 21); current availability not found |
| Diltiazem 100 mg ADD-Vantage vial | NDC 00409-4350-03 | Pfizer (Hospira) | To Be Discontinued per FDA (posted Jan. 5); Depleted on Pfizer's undated product page |
Same-drug listings are not automatic substitutes. Baxter's labetalol 200 mg/40 mL vial differs in volume and dose per vial from the stocked-out 100 mg/20 mL vial. Nexterone 150 mg/100 mL differs in strength and concentration from the 360 mg/200 mL bag. Those decisions belong to clinical teams and P&T.
How is this affecting healthcare buyers and facilities?
- An FDA check alone can miss the constraint. A stocked-out labetalol vial and a limited Nexterone bag both sit outside FDA's current shortage records.
- Forecasting has to happen by NDC. At Baxter, labetalol 100 mg/20 mL is out while 200 mg/40 mL is available, and Nexterone 360 mg is limited while 150 mg is available.
- Recovery dates are soft. Baxter's estimates have moved repeatedly, and its 20 mg/4 mL labetalol recovery slipped from Q1 2027 to Q2 2027 between the Oct. 16 and Oct. 23 reports.
- Recalls add lot-level work. Some recalled lots do not expire until 2028, so affected stock could still be on shelves or in kits.
What should facilities do when supply is tight?
- Check inventory by lot number. Compare stock against the recalled Nexterone, Cardene and Civica-labeled lots. For its lots, Baxter tells customers to isolate them, stop using them, and arrange return and replacement through Baxter, or through the wholesaler if bought there. California's Aug. 19 notice says five affected product codes carry separate carton and container NDCs, so match by lot, not NDC alone.
- Add manufacturer reports to the weekly routine. They carry status FDA's list does not. Treat their dates as estimates, not commitments.
- Ask suppliers specific questions. Ask Baxter how to read Supply Available beside a Q2 2027 recovery date on labetalol 20 mg/4 mL. Ask Pfizer about the 200 mg/40 mL vial and ADD-Vantage diltiazem.
- Test whether alternate labels are independent. Baxter's labetalol label, dated November 2025, names Caplin Steriles Limited as manufacturer, and Caplin also has its own labeler listings. A different label may not mean separate supply, and a label does not show a product is shipping. This is a question to raise, not a finding.
- Use pharmacy and P&T governance. Therapeutic interchange and protocol changes belong to clinical teams. Moving from a premix to a vial also adds compounding steps.
Where can buyers monitor supply information through PRN?
Start with the Drug Shortage News hub for market context and the drug shortage index for category review. High-Demand Products and the FAQ cover adjacent pressure points and operational questions.
If your team needs sourcing support for a specific NDC, use Request a Custom Quote. New licensed facilities can start through customer onboarding.
Need help planning around labetalol, Nexterone or other IV cardiovascular constraints? Request a Custom Quote for sourcing support by NDC, or start customer onboarding if your facility needs a purchasing account.
Important note: This article is intended for general informational and procurement reference only. It is not medical, legal, or regulatory advice. Facilities should confirm current shortage status, recall lot status, labeling, concentration, container, interchangeability, and purchasing decisions through current manufacturer, distributor, FDA, pharmacy, and institutional review channels before acting.