FDA Extends Drug Use Dates Due to Shortages

FDA Drug Shortages

Published September 18th, 2025

Detected March 13th, 2026

Summary

The FDA has extended the use dates for specific lots of certain drugs to help alleviate drug shortages. This guidance allows providers and patients to use these lots beyond their labeled expiration dates, based on manufacturer stability data. The agency is not requiring relabeling but expects replacement and disposal when new product becomes available.

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What changed

The FDA has published a searchable table listing specific lot numbers of drugs for which stability data supports an extended use date. This action is intended to mitigate drug shortages by allowing healthcare providers and patients to utilize existing stock for longer periods. The agency has reviewed manufacturer-provided stability data to support these extensions for products such as Meperidine hydrochloride injection, Ethiodized oil injection, and Dantrolene sodium for injectable suspension.

While the FDA is not mandating relabeling, it expects that lots identified in the table will be replaced and properly disposed of once replacement product becomes available during the extension period. Healthcare providers and patients should consult the table for specific lot numbers and their corresponding extended use dates. Questions regarding this guidance should be directed to the CDER Drug Shortage Staff.

What to do next

Review the FDA's list of extended drug use dates for relevant lot numbers.
Utilize extended-dated products to manage drug supply during shortages.
Replace and dispose of extended-dated products when replacement stock becomes available.

Source document (simplified)

Based on stability data provided by the manufacturers and reviewed by FDA, the following extended use dates are supported for specific lot numbers indicated in the searchable table below. Providers and patients that have the lot numbers in stock will be able to use them through the corresponding new use dates to help with supply. As data become available, this list can continue to expand.

FDA is not requiring or recommending that the identified lot numbers in the following table be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then the agency expects the lots in these tables will be replaced and properly disposed of as soon as possible.

Please contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov with questions regarding this table.

| Product | Company | NDC Number | Lot Number | Expiration Date (Labeled) | Extended Use Date |
| --- | --- | --- | --- | --- | --- |
| Meperidine hydrochloride injection, 50 mg/mL, single dose cartridge with luer-lock, carton of 10 | Hospira, a Pfizer company | 0409-1178-30 | HN8657 | 30-Sep-2025 | 30-Jan-2026 |
| Ethiodized oil injection, 480 mg Iodine/mL, single dose vial | Guerbet | 67684-1901-2 | 24LF701A | 31-Dec-2025 | 31-Mar-2026 |
| Dantrolene sodium for injectable suspension, 250 mg, single-dose vial | Eagle Pharmaceuticals, Inc. | 42367-540-32 | B235030 | 30-Sep-2025 | 30-Jun-2026 |
| Dantrolene sodium for injectable suspension, 250 mg, single-dose vial | Eagle Pharmaceuticals, Inc. | 42367-540-32 | B235034 | 31-Oct-2025 | 31-Jul-2026 |