Methohexital Sodium, 100 mg/10 mL recall — Quva Pharma, Inc. (Class II)

Quva Pharma, Inc. is recorded by the U.S. Food and Drug Administration (FDA) as recalling Methohexital Sodium, 100 mg/10 mL — a Class II recall, initiated 2026-06-24 and posted to the FDA enforcement report on 2026-07-15, under recall number D-0664-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Failed Impurities/Degradation Specifications”. From the product description, the strengths given are 100 mg/10 mL, 10 mg/mL and 10 mL and it is marked Rx only. Distribution is recorded as “Nationwide within the United States” — Nationwide (US), with the recalling firm on record in TX, United States. It is the only recall number the FDA has filed under event ID 99311. 2 indexed records name methohexital sodium as the recalled substance. 21 days separate the firm's initiation date from the FDA's report date on this record. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.

Regulatory snapshot

Recall number D-0664-2026
FDA event ID 99311
Classification Class II (intermediate regulatory tier)
Status Ongoing
Recalling firm Quva Pharma, Inc.
Recall initiated 2026-06-24
Reported by FDA 2026-07-15
Report lag 21 days from initiation to report
Distribution Nationwide within the United States — Nationwide (US)
Firm location on record TX, United States
Product description (source) 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.

Reason reported by FDA

Failed Impurities/Degradation Specifications

3 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

4 identifying values matched by exact pattern in the 31-word product description above; each is a literal substring of it.

Product named Methohexital Sodium
Strength 100 mg/10 mL · 10 mg/mL · 10 mL
Marketing category Rx only

Other indexed recalls of methohexital sodium

2 indexed records name methohexital sodium as the recalled substance. Matching is on the product-name prefix of the FDA's own text, so other strengths and packages are included.

Recall recordRecall numberRecalling firmStrength / formReported
Methohexital Sodium for Injection, 500 mgD-0662-2026Onesource Specialty Pharma Ltd500 mg · for Injection2026-07-15

Reported in the same month (2026-07)

111 enforcement reports carry a report date in 2026-07; these 8 are the Class II ones nearest this record.

Recall recordRecall numberRecalling firmFDA tierReported
Medline Remedy Specialized Silicone Cream (Hydraguard-D ), 59 mLD-0663-2026Biomed Laboratories, Llc.Class II2026-07-15
Gasco Isopropyl Alcohol 70%D-0665-2026Gasco Industrial Corp.Class II2026-07-15
Gasco Isopropyl Alcohol 70%D-0666-2026Gasco Industrial Corp.Class II2026-07-15
Gasco Isopropyl Alcohol 70%D-0667-2026Gasco Industrial Corp.Class II2026-07-15
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%D-0668-2026Gasco Industrial Corp.Class II2026-07-15
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%D-0669-2026Gasco Industrial Corp.Class II2026-07-15
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%D-0670-2026Gasco Industrial Corp.Class II2026-07-15
Pemetrexed for Injection 100mg/VialD-0671-2026Reliance Life Sciences Private LtdClass II2026-07-15

Nearest Class II recalls by date

213 of 250 indexed records share the Class II tier; the 7 nearest to 2026-07-15 by report date are listed here.

Recall recordRecall numberRecalling firmStrength / formReported
Pemetrexed for Injection 500mg/VialD-0672-2026Reliance Life Sciences Private Ltd500mg/Vial · for Injection2026-07-15
Bortezomib for Injection 3.5mg/VialD-0673-2026Reliance Life Sciences Private Ltd3.5mg/Vial · for Injection2026-07-15
Azacitidine for Injection 100mg/VialD-0674-2026Reliance Life Sciences Private Ltd100mg/Vial · for Injection2026-07-15
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), 1 KGD-0691-2026Shimoga Chemicals1 KG2026-07-15
BD ChloraPrep Hi-Lite Orange, 2%D-0643-2026Carefusion 213, LLC2% · Solution2026-07-08
BD PurPrep, 8.3%D-0644-2026Carefusion 213, LLC8.3% · Solution2026-07-08
BD ChloraPrep Clear, 2%D-0645-2026Carefusion 213, LLC2% · Solution2026-07-08

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Quva Pharma, Inc. (1 indexed records) aggregates this firm across datasets.

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0664-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.

Source & provenance

Official source
https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0664-2026%22
Source dataset
openFDA Drug Enforcement API
Publication date
2026-07-15
Ingested
2026-08-22
Record hash
da27881785c7f410

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.