thejoe Diazepam

Diazepam recalls: 7 FDA reports

Recalls involving Diazepam. What was wrong with each batch, and how the FDA graded the risk.

7Reports

0Class I

0Ongoing

2018-08-15Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	6
Class III	1

By year reported

Year	Reports
2012	1
2013	4
2016	1
2018	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with l

D-1041-2018 · Class III · reported 2018-08-15 · Terminated

Why it was recalled: Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Product: Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20.
Where it went: Nationwide in the USA
How much: 306 cartons

Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-3

D-1359-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Crystallization: Product contains particulate identified to be crystallized active ingredient.
Product: Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
Where it went: Nationwide
How much: 373,850 tubes

Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hos

D-927-2013 · Class II · reported 2013-09-04 · Terminated

Why it was recalled: Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Product: Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12
Where it went: Nationwide and Puerto Rico
How much: 72,300 vials

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 600

D-501-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Product: Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Where it went: Nationwide and Puerto Rico
How much: 95,700 vials

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 600

D-313-2013 · Class II · reported 2013-05-15 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Product: Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Where it went: Nationwide and Puerto Rico
How much: 114,000 vials

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 600

D-309-2013 · Class II · reported 2013-05-08 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Product: Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Where it went: Nationwide and Puerto Rico
How much: 172,350 vials

Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count aut

D-1369-2012 · Class II · reported 2012-06-20 · Terminated

Why it was recalled: Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Product: Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian Medical Technologies, Columbia, MD 21046; A subsidiary of King Pharmaceuticals, Inc.; NSN 6505-01-274-0951, NDC 11704-600-01.
Where it went: Nationwide, military, Italy, Singapore, Sweden, and Canada.
How much: 83,400 autoinjectors

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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