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Class II Recall — Risk of Temporary or Reversible Adverse Health Consequences
Verified · FDAClass II — Possible RiskMedications

FEBUXOSTAT Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed Recall 2024

FEBUXOSTATIssued January 25, 2024

FEBUXOSTAT Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11 — recalled per FDA on 1/25/2024. Reason: CGMP Deviations.

Issuing agency
FDA
Issued
Jan 25, 2024
Brand
FEBUXOSTAT
Distribution
1 states

What to do right now

  1. 1

    Stop using it

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

  2. 2

    Verify the match

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

  3. 3

    Return or dispose

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

Verified source

U.S. Food and Drug Administration

Summary of the official FDA notice issued January 25, 2024. Last synced Apr 27, 2026. View on fda.gov

What's recalled

Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11

Why it was recalled

CGMP Deviations

Affected products & lot numbers
4 lots called out

Affected Lot Numbers

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

Lot Number
Lot # 1015033
exp. 06/30/2025
1016409
exp. 08/31/2025
Where was it sold
1 state

USA Nationwide

nationwide
View official FDA notice

View all questions for this recall →

More recalls like this
6 related — by brand, contaminant, and category

Frequently asked questions

Is the FEBUXOSTAT recall still active?

Yes, this recall is currently active as of January 25, 2024. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot # 1015033, exp. 06/30/2025, 1016409, exp. 08/31/2025. Check the label on your product.

What should I do if I have the recalled FEBUXOSTAT?

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