RECALL DATABASE

Paroxetine Recall: Apotex 37.5 mg Rx

Announced 2026-10-07 · FDA

Paroxetine Extended-Release Tablets, 37.5 mg, 30-count bottle, Rx only, distributed nationwide in the US, are recalled due to failed dissolution specifications. The recalled lot TY9495 has expiration date 05/2027.

BrandApotex Corp.
ProductParoxetine 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
ReasonFailed dissolution specifications.
Severitymoderate
DistributionUS Nationwide.
AgencyFDA

WHAT YOU SHOULD DO

  1. Do not use any tablets from lot TY9495 with expiration date 05/2027.
  2. Contact your pharmacist or healthcare provider for guidance and a possible replacement.
  3. Follow the recall instructions for returning or disposing of the product.

How to identify the recalled item

Lot / date codesLot# TY9495, Exp Date: 05/2027.
Lot / date codesLot# TY9495, Exp Date: 05/2027.

These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.

Other Apotex Corp. recalls

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This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.