CLASS III Drug recall · Reported 18 Nov 2015 · FDA Enforcement Report
Duloxetine Delayed-release Capsules, USP, 60 mg recalled
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-release Capsules, USP, 60 mg, distributed nationwide in the US. The recall was initiated on 21 Oct 2015 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-0181-2016
- FDA event ID
- 72563
- Recalling firm
- Breckenridge Pharmaceutical, Berlin, CT
- Brand
- Duloxetine
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Oct 2015
- FDA classified
- 10 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 21 Oct 2015 | Recall initiated by company | |
| 10 Nov 2015 | Classified by FDA | +20 days |
| 18 Nov 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Product as listed by the FDA
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Which lots are affected?
Lot #: 142391, Exp 10/2016
Where was it sold?
Nationwide
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 26 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 Breckenridge Pharmaceutical
All 35| 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 Delayed-Release Capsules USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
Other Duloxetine recalls
All 57| 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 |