CLASS II ONGOING Drug recall · Reported 25 Dec 2024 · FDA Enforcement Report
Dihydroergotamine Mesylate Injection, solution recalled by Provepharm
Provepharm is recalling Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, distributed nationwide in the US. The recall was initiated on 22 Nov 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0150-2025
- FDA event ID
- 95772
- Recalling firm
- Provepharm, Collegeville, PA
- Manufacturer
- Provepharm Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2024
- FDA classified
- 16 Dec 2024
- Reported
- 25 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Nov 2024 | Recall initiated by company | |
| 16 Dec 2024 | Classified by FDA | +24 days |
| 25 Dec 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules recalled?
Yes. Provepharm recalled Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules on 22 Nov 2024. The recall is Class II and its status is Ongoing. Recall number D-0150-2025.
Why was it recalled?
Discoloration
Which lots are affected?
Lot #: F9026F01, F9026F02, Exp. Date 12/2025
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Provepharm
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled | Provepharm | Particulate Matter | Nationwide |