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Mallinckrodt Hospital Products Inc. Acthar Gel , 5 mL multiple-dose vial Recall 2026

Mallinckrodt Hospital Products Inc.Issued August 6, 2026Updated Reviewed by the Recall Watch editorial team

Mallinckrodt Hospital Products Inc. 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 — recalled per FDA on 8/6/2026. Reason: Presence of particulate matter: glass and stopper piece.

Agency
FDA
Issued
Aug 6, 2026
Brand
Mallinckrodt Hospital Products Inc.
Distribution
1 states
Lots affected
3
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued August 6, 2026 · Last synced Nov 1, 2026

What's recalled

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

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Why it was recalled

Presence of particulate matter: glass and stopper piece

Affected products & lot numbers
3 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot#: NDC 63004-8710-1 - 1564-107
exp 1/31/2027 NDC 63004-8710-2 - 1564-107H
exp 1/31/2027
Where was it sold
1 state

USA Nationwide

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the Mallinckrodt Hospital Products Inc. recall still active?

Yes, this recall is currently active as of August 6, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027. Check the label on your product.

What should I do if I have the recalled Mallinckrodt Hospital Products Inc.?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.