Drug recall: Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario…

Class II FDA enforcement event 99978. Recall start date: 23 Sep 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Failed dissolution specifications.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Apotex Corp. started this drug recall on 23 Sep 2026. The firm address in the FDA record is in Weston, FL. FDA put the recall in Class II. FDA event 99978 has 1 product record. The first FDA enforcement report date is 7 Oct 2026. The record gives the status Ongoing. 72 of the 258 drug events that started in 2026 have more product records. The median drug event of 2026 has 1 product record.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 27 Oct 2026.

Distribution

In the words of FDA.

US Nationwide.

Recalling firm

Apotex Corp., Weston, FL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 99978: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0877-2026	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		Class II	Ongoing	7 Oct 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2026: 258
Share of these events in Class II: 75%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 25

Other events of the firm

Other FDA enforcement events of Apotex Corp.
Initiated	Product (first record)	Type	Class	Records
13 Aug 2026	Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto,	Drug	Class II	1
8 Apr 2026	Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Ca	Drug	Class II	1
5 Mar 2026	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured f	Drug	Class II	1
5 Sep 2025	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufacture	Drug	Class II	2
28 May 2025	Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada	Drug	Class II	3
28 May 2025	Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9	Drug	Class II	1
9 Feb 2024	Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc.	Drug	Class II	1
1 Nov 2023	Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#:	Drug	Class II	4
26 Apr 2023	Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/s	Drug	Class II	1
1 Mar 2023	Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60	Drug	Class II	1

Apotex Corp.: all 25 events

Official channels

FDA enforcement report D-0877-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 99978. https://recallregister.com/fda/ii/99978/. Source: openFDA enforcement reports. Data through 27 Oct 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 27 Oct 2026
Newest FDA report date on the register: 21 Oct 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2026 have the same class?: 75% of the 258 drug events that started in 2026 are in Class II.
How many FDA recalls does Apotex Corp. have?: Apotex Corp. is the recalling firm in 25 enforcement events on this register. This event is 1 of them.