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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Dihydroergotamine Mesylate Injection Recalled for Discoloration

Agency Publication Date: December 16, 2024
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Summary

Provepharm Inc. is recalling 10,800 ampules (2,160 packs) of Dihydroergotamine Mesylate Injection (1 mg/mL), a prescription medication used to treat migraine headaches. The recall was initiated because the solution in the ampules may show discoloration. Consumers should check their supply for lot numbers F9026F01 and F9026F02 with an expiration date of December 2025. Provepharm Inc. notified customers of this voluntary recall via letter.

Risk

Discoloration in an injectable medication indicates a potential change in the drug's chemical stability or composition. Using discolored medication may result in reduced effectiveness of the treatment or could potentially cause an adverse reaction when administered.

What You Should Do

  1. This recall affects Dihydroergotamine Mesylate Injection, USP, 1 mg/mL Ampules distributed by Provepharm Inc. under NDC 81284-411-05.
  2. Identify affected products by looking for lot numbers F9026F01 or F9026F02 and the expiration date 12/2025 printed on the ampule packaging.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dihydroergotamine Mesylate Injection (1 mg/mL)
Variants: solution for injection, USP, 1 mg/mL, Ampules, Rx Only
Lot Numbers:
F9026F01 (Exp 12/2025)
F9026F02 (Exp 12/2025)
NDC:
81284-411-05

Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426. Quantity: 2160 packs/5 ampules per pack = 10,800 ampules.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95772
Status: Active
Manufacturer: Provepharm Inc.
Manufactured In: United States
Units Affected: 2160 packs/5 ampules per pack = 10,800 ampules
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.