Dihydroergotamine Mesylate Injection recall
FDA recall D-0150-2025 · initiated Nov 22, 2024
Provepharm Inc. recalled Dihydroergotamine Mesylate Injection in Nov 2024 — an FDA Class II recall (D-0150-2025) because Discoloration.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Discoloration
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 2160 packs/5 ampules per pack = 10,800 ampules
Details
- Product
- Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05
- Recalling company
- Provepharm Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Nov 22, 2024
- FDA report date
- Dec 25, 2024
Frequently asked
- Was Dihydroergotamine Mesylate Injection recalled?
- Provepharm Inc. recalled Dihydroergotamine Mesylate Injection in Nov 2024 — an FDA Class II recall (D-0150-2025) because Discoloration. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Dihydroergotamine Mesylate Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0150-2025 was: Discoloration
- Is a recalled Dihydroergotamine Mesylate 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 Dihydroergotamine Mesylate Injection are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: F9026F01, F9026F02, Exp. Date 12/2025. 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-0150-2025.