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Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only Recall 2024

BUDESONIDEIssued January 8, 2024Updated Reviewed by the Recall Watch editorial team

BUDESONIDE Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ — recalled per FDA on 1/8/2024. Reason: Failed Dissolution Specifications.

Agency
FDA
Issued
Jan 8, 2024
Brand
BUDESONIDE
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 January 8, 2024 · Last synced Apr 27, 2026

What's recalled

Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30

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Why it was recalled

Failed Dissolution Specifications

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 # 100047273
Exp. 07/2025
Where was it sold
1 state

Nationwide

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

Frequently asked questions

Is the BUDESONIDE recall still active?

Yes, this recall is currently active as of January 8, 2024. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot # 100047273, Exp. 07/2025. Check the label on your product.

What should I do if I have the recalled BUDESONIDE?

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