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Verified · FDAClass III — Low RiskMedications

Revcovi Injection, 2.4mg/1.5mL , Single-Dose Vial, Rx Only, For Intramuscular Recall 2026

REVCOVIIssued August 19, 2026Updated Reviewed by the Recall Watch editorial team

REVCOVI Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01 — recalled per FDA on 8/19/2026. Reason: Failed Stability Specifications: Out of specification stability result for the protein concentration profile..

Agency
FDA
Issued
Aug 19, 2026
Brand
REVCOVI
Distribution
1 states
Lots affected
2
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 19, 2026 · Last synced Nov 1, 2026

What's recalled

Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01

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Why it was recalled

Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

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

Lot Number
Lot#: 1221973
Exp 3/24/2027
Where was it sold
1 state

MO, TN

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

Frequently asked questions

Is the REVCOVI recall still active?

Yes, this recall is currently active as of August 19, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot#: 1221973, Exp 3/24/2027. Check the label on your product.

What should I do if I have the recalled REVCOVI?

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