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Paxil CR Paroxetine 37.5mg Tablets
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DRUG RECALLMODERATE

Paxil CR Paroxetine 37.5mg Tablets

Apotex recalls Paxil CR 37.5mg tablets for failing dissolution specs.

What to do

Consumers who have this product should stop using it and return it to the place of purchase or contact Apotex Corp. for a refund or replacement. Consult your healthcare provider before discontinuing or switching medication.

Recalled
Listed
Updated
Recall No.
D-0804-2026
Agency
FDA
Firm
Apotex Corp.
Recall ID
99673
Status
ONGOING

Recall at a glance

Quantity recalled
6,972 bottles

Why it was recalled

Apotex Corp. is recalling Paxil CR (paroxetine) extended-release tablets, 37.5 mg, 30-count bottles, because the product failed dissolution specifications and did not meet 24-month stability testing acceptance criteria. This may affect the drug's effectiveness.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Paxil CR, Paroxetine, Extended-Release Tablets

Lot code
TY9494, 2027
Strength
37.5 mg
NDC / UPC
NDC 60505-4379-3

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Dissolution Failure recalls

Other recent recalls from Apotex Corp.

All recalls from Apotex Corp.

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Editorial summary by Recall Canary · summary updated 2026-08-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification