Official recall notice

FDA DrugClass IINotable

Acthar Gel multiple-dose vial Recall (Sep 2026)

Product: Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2

Recall date
2026-09-02
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Presence of particulate matter: glass and stopper piece

One email a week when there are new recalls. Confirm by email; unsubscribe anytime.

Product description

Presence of particulate matter: glass and stopper piece

Affected products

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

Verify with the official notice →
Share:

Related Recalls

2026-10-21 · FDA_DRUG
FDA Recall: No Brand Name: Compounded veterinary medications
No Brand Name
2026-10-14 · FDA_DRUG
FDA Recall: Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry a
K.C. Pharmaceuticals, Inc.
2026-10-14 · FDA_DRUG
FDA Recall: Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HE
K.C. Pharmaceuticals, Inc.
2026-10-14 · FDA_DRUG
FDA Recall: Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario,
SUN PHARMACEUTICAL INDUSTRIES INC