Skip to main content
Skip to recall details
Verified · FDAClass II — Possible RiskMedications

Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only Recall 2026

PAROXETINE HYDROCHLORIDEIssued September 23, 2026Updated Reviewed by the Recall Watch editorial team

PAROXETINE HYDROCHLORIDE 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- — recalled per FDA on 9/23/2026. Reason: Failed dissolution specifications..

Agency
FDA
Issued
Sep 23, 2026
Brand
PAROXETINE HYDROCHLORIDE
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.

Free case review

Were you or someone in your household prescribed this medication?

  • Free
  • No obligation
  • Licensed attorneys
Attorney advertising.Details

Recall Watch is not a law firm and does not provide legal or medical advice. Free case reviews are provided by independent licensed attorneys; Recall Watch may receive a referral fee. Prior results do not guarantee a similar outcome. Submitting this form does not create an attorney-client relationship. See our terms and privacy policy.

Verified summary of the official U.S. Food and Drug Administration notice · Issued September 23, 2026 · Last synced Oct 14, 2026

What's recalled

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 60505-1318-3

Available at AmazonAd
White first-aid box with bandages

Restock your medicine cabinet

First-aid kits, thermometers and OTC basics, searched on Amazon.

Shop at Amazon.com

Need it delivered? Start a free Amazon Prime trial.

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# TY9495
Exp Date: 05/2027.
Where was it sold
1 state

US Nationwide.

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

Frequently asked questions

Is the PAROXETINE HYDROCHLORIDE recall still active?

Yes, this recall is currently active as of September 23, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot# TY9495, Exp Date: 05/2027.. Check the label on your product.

What should I do if I have the recalled PAROXETINE HYDROCHLORIDE?

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