Methohexital Sodium for Injection recall
FDA recall D-0662-2026 · initiated Jun 7, 2026
ONESOURCE SPECIALTY PHARMA LIMITED recalled Methohexital Sodium for Injection in Jun 2026 — an FDA Class II recall (D-0662-2026) because Failed Impurities/Degradation Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4284 vials
Details
- Product
- Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
- Recalling company
- Onesource Specialty
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jun 7, 2026
- FDA report date
- Jul 15, 2026
Frequently asked
- Was Methohexital Sodium for Injection recalled?
- ONESOURCE SPECIALTY PHARMA LIMITED recalled Methohexital Sodium for Injection in Jun 2026 — an FDA Class II recall (D-0662-2026) because Failed Impurities/Degradation Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Methohexital Sodium for Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0662-2026 was: Failed Impurities/Degradation Specifications
- Is a recalled Methohexital Sodium for Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Methohexital Sodium for Injection are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 7000612A, Exp. Date 1/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0662-2026.