Apotex Recalls Duloxetine 60mg Due to Dissolution Failure
Apotex recalls Duloxetine Delayed-Release Capsules, USP, 60 mg because of failed dissolution specifications. Check lot numbers and expiration dates.
Use caution until it’s fixed
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Contact the company
What happened, in plain English
Apotex Scientific, Inc is recalling Duloxetine Delayed-Release Capsules, USP, 60 mg in 30-count bottles due to failed dissolution specifications during stability testing. This means the medication may not release properly in the body. The recall affects approximately 605,989 bottles distributed nationwide. Read more at govinfonow.com/recall/43209-apotex-recalls-duloxetine-60mg-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/43209-apotex-recalls-duloxetine-60mg-due-to-dissolution-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-1436-2016
Cite this page
“Apotex Recalls Duloxetine 60mg Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43209-apotex-recalls-duloxetine-60mg-due-to-dissolution-failure. Based on FDA recall #D-1436-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1436-2016%22&limit=1).
Why it’s dangerous
The product failed dissolution specifications, which is a quality control measure to ensure the drug releases its active ingredient correctly. If the capsules do not dissolve properly, patients may not receive the full therapeutic dose, potentially leading to ineffective treatment of their condition.
Who’s affected
Patients who have been prescribed Duloxetine 60 mg capsules manufactured by Apotex Inc and purchased between the lot release dates and expiration dates listed in the record. Individuals with these specific lot numbers are at risk of receiving medication that does not dissolve as intended.
How to tell if you have this one
Check your bottle for NDC 60505-2997-3 and UPC # 360505299737. Verify the lot number against KW2167, KY9960, KV9789, KV9788 (Exp 02/29/2016); KY9961 (Exp 04/30/2016); KX6311, KX6312, KY7795, KX6315 (Exp 05/31/2016); or KX6317 (Exp 06/30/2016). The product is Rx only and manufactured by Apotex Inc in Toronto for Apotex Corp in Weston, Florida.
- Brand
Apotex- Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide, Alaska, Hawaii, and Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1435-2016 | Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;; Lot #: KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016. | 107,880 (60 ct bottle) |
| D-1436-2016 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;; Lot #: KW2167,KY9960, KV9789, KV9788; Exp 02/29/2016; Lot #: KY9961, Exp 04/30/2016; Lot #: KX6311, KX6312, KY7795, KX6315, Exp 05/31/2016; Lot #: KX6317, Exp 06/30/2016. | 605,989 (30 ct) bottles |
| D-1437-2016 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.; Lot #: KY5120, KW2164, KY9953, KV9791, KV9792, Exp 03/31/2016. | 750,273 (30 ct) bottles |
What to do — step by step
Check your medication
Verify if your Duloxetine bottle matches the recalled NDC, UPC, lot numbers, or expiration dates listed in the record.
Contact your pharmacist
If you have a recalled bottle, contact your pharmacy or healthcare provider to discuss returning the product and obtaining a replacement.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “Nationwide, Alaska, Hawaii, and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Hawaii, Puerto Rico.
Recall timeline
FDA terminated this recall 6.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this product distributed?
The product was distributed nationwide, including Alaska, Hawaii, and Puerto Rico.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1436-2016 (January 26, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1436-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.