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Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle Recall 2026

Apotex Corp.Issued August 13, 2026Updated Reviewed by the Recall Watch editorial team

Apotex Corp. Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, — recalled per FDA on 8/13/2026. Reason: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria.

Agency
FDA
Issued
Aug 13, 2026
Brand
Apotex Corp.
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 13, 2026 · Last synced Nov 1, 2026

What's recalled

Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3

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Why it was recalled

Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

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 # TY9494
Exp Date: 05/31/2027.
Where was it sold
1 state

US Nationwide.

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

Frequently asked questions

Is the Apotex Corp. recall still active?

Yes, this recall is currently active as of August 13, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot # TY9494, Exp Date: 05/31/2027.. Check the label on your product.

What should I do if I have the recalled Apotex Corp.?

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