The Recall Desk
SevereFDA (Drugs)·D-0803-2026·Announced 2026-09-02

ACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter

Mallinckrodt is recalling ACTHAR Gel vials due to the presence of glass and stopper pieces. Patients should stop using the product and contact their healthcare provider.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury (such as particulate matter in an injectable drug) are categorized as Severe (Score 4).

Plain-English summary

Mallinckrodt Hospital Products Inc. is recalling 12,367 vials of ACTHAR (repository corticotropin) Gel, 5 mL multiple-dose vials, due to the presence of particulate matter, specifically glass and stopper pieces. The affected product is distributed nationwide in the United States.

The recall involves specific lots of ACTHAR Gel with NDC 63004-8710-1 and NDC 63004-8710-2. Both lots have an expiration date of January 31, 2027. The product is a prescription-only medication administered via intramuscular or subcutaneous injection.

Patients and healthcare providers should stop using the affected vials immediately. Individuals who have received injections from these vials should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
ACTHAR (REPOSITORY CORTICOTROPIN)
Brand
ACTHAR
Manufacturer
Mallinckrodt Hospital Products Inc.
Category
Drug — Prescription Injectable
Hazard
Affected units
12,367

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot#: NDC 63004-8710-1 - 1564-107
  • exp 1/31/2027 NDC 63004-8710-2 - 1564-107H
  • exp 1/31/2027

UPCs (1)

  • 0363004871213

Distribution

Distributed nationwide across the United States.

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Same manufacturer · Mallinckrodt Hospital Products Inc.

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Same hazard · particulate matter

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