openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 3
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Code information
Lot # a) Lot GS041383, GS042141, Exp. 08/31/2024; b) Lot GS040841, Lot GS041384, Lot GS042039, Exp. 08/31/2024; c) Lot GS040910, Lot GS041621, Lot GS042237, Exp. 08/31/2024;
Distribution pattern
Nationwide in the USA
drug · product 2 of 3
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Code information
Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;
Distribution pattern
Nationwide in the USA
drug · product 3 of 3
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.
Potency or specification failurereason.potency_specification_failure · v1.0.0
Out of specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Code information
Lot # a) GS036488, GS037091, GS037701, Exp. 08/31/2024; b) GS037090, GS037702, Exp. 08/31/2024; c) GS036677, GS037117, GS037699, Exp. 08/31/2024
