FDA-Drug2023-12-06Class II
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Hazard
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Sold states
Nationwide in the USA
Affected count
5626 bottles
Manufactured in
5187 Camino Ruiz, Camarillo, CA, United States
Products
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0130-2024More Golden State Medical Supply Inc. recalls
- FDA-Drug2026-06-17Golden State Medical Supply niacin extended-release tablets recalled for failed dissolution
- FDA-Drug2026-05-27Golden State Medical Supply Primidone Tablets recalled for Acemetacin contamination
- FDA-Drug2026-05-27Golden State Medical Supply Primidone tablets recalled for Acemetacin contamination
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