FDA Extends Use Dates on Hospira, Baxter Vials Amid Shortages

Stability-data reviews by FDA's Center for Drug Evaluation and Research (CDER) have produced extended use dates for specific lots of three critical injectables, bupivacaine spinal injection, dextrose injection 25%, and flumazenil injection, manufactured by Hospira, a Pfizer company, and Baxter, providing facilities holding these lots a defined compliance window before disposal obligations apply.

The extension covers fourteen lot numbers across the three products. Six lots of Bupivacaine Spinal Injection 0.75% in Dextrose 8.25% (glass ampule) from Hospira carry extended use dates ranging to 28 February 2027. Six lots of Dextrose Injection 25% plastic syringes, also from Hospira, are extended to 1 October 2026 from a labeled expiry of 1 May 2026. Two lots of Flumazenil Injection 0.1 mg/mL (10 mL vial) from Baxter are extended from 31 July 2026 to 31 January 2027.

For QA directors and pharmacy operations leads, the relabeling question is settled: FDA is not requiring or recommending that affected lot numbers be relabeled with the new use dates. Inventory management and documentation controls must therefore reflect the extended dates at the lot level without physical label changes, a distinction that warrants a review of site-level SOPs governing expiry tracking and dispensing verification.

The disposal obligation is equally precise. Where replacement product becomes available during the extension period, FDA expects the extended lots to be replaced and properly disposed of as soon as possible, language that places a conditional but firm obligation on supply-chain and QA teams to monitor replenishment status and act promptly. Facilities should establish a trigger-based review cadence tied to distributor availability notifications for these NDCs.

FDA notes the searchable table will expand as additional stability data are submitted and reviewed, meaning the lot-level compliance picture for these and potentially other shortage-affected products remains dynamic. CDER Drug Shortage Staff can be reached at [email protected] for lot-specific questions.

The next measurable checkpoint for affected facilities is the 1 October 2026 extended use date on Dextrose Injection 25% lots LH7103, LH7106, and LH7108, the nearest expiry in the current table.

Source: FDA CDER via FDA.gov Drugs RSS Feed, 27 August 2026.