CLASS III Drug recall · Reported 20 Jul 2016 · FDA Enforcement Report
Duloxetine Delayed-Release Capsules, USP, 30 mg recalled
Apotex Scientific is recalling Duloxetine Delayed-Release Capsules, USP, 30 mg, distributed nationwide in the US. The recall was initiated on 26 Jan 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1437-2016
- FDA event ID
- 73419
- Recalling firm
- Apotex Scientific, Arlington, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Jan 2016
- FDA classified
- 14 Jul 2016
- Reported
- 20 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 26 Jan 2016 | Recall initiated by company | |
| 14 Jul 2016 | Classified by FDA | +170 days |
| 20 Jul 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide, Alaska, Hawaii, and Puerto Rico.
Questions about this recall
Is Duloxetine Delayed-Release Capsules, USP, 30 mg recalled?
Yes. Apotex Scientific recalled Duloxetine Delayed-Release Capsules, USP, 30 mg on 26 Jan 2016. The recall is Class III and its status is Terminated. Recall number D-1437-2016.
Why was it recalled?
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Which lots are affected?
Lot #: KY5120, KW2164, KY9953, KV9791, KV9792, Exp 03/31/2016.
Where was it sold?
Nationwide, Alaska, Hawaii, and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Apotex Scientific
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Duloxetine Delayed-Release Capsules, USP, 20 mg recalled | Apotex Scientific | Potency & Assay | Nationwide |
| Drug | CLASS III | Duloxetine Delayed-Release Capsules, USP, 60 mg recalled | Apotex Scientific | Potency & Assay | Nationwide |
Other Duloxetine recalls
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine DR Capsules, 30 mg, Rx, Relabeled recalled by Asclemed USADuloxetine | Asclemed USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg recalled by Ajanta PharmaDuloxetine | Ajanta Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |