Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park On
Summary
The FDA issued a Class II for Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Comp by QuVa Pharma, Inc.. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0664-2026
Action Date
2026-07-15
Status
Ongoing
Category
drug
Product Description
Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.
Lot/Code Info: Lot #: 10162261, 10162262, 10162279, 10162280, Exp. Date 07/21/2026; 10162314, 10162315, Exp. Date 07/22/2026; 10162465, 10162466, 10162491, 10162492, Exp. Date 07/26/2026; 10162542, 10162543, Exp. Date 07/27/2026; 10162559, 10162560, Exp. Date 07/28/2026; 10162623, 10162624, Exp. Date 07/29/2026; 10162693, 10162694, Exp. Date 07/30/2026; 10162735, 10162736, 10162753, 10162754, Exp. Date 07/31/2026; 10162772, 10162773, 10162791, 10162792, 10162810, 10162811, Exp. Date 08/02/2026; 10162820, Exp. Date 08/03/2026; 10162853, 10162854, Exp. Date 08/04/2026; 10163046, Exp. Date 08/09/2026; 10163156, 10163157, Exp. Date 08/10/2026.
Quantity Affected: N/A
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-24
Company
Sugar Land, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 44 drug recalls issued in the same week, part of 93 drug-related FDA actions this month.
QuVa Pharma, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (QuVa Pharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does QuVa Pharma, Inc. have FDA actions?
QuVa Pharma, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0664-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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