CLASS II Drug recall · Reported 8 Oct 2014 · FDA Enforcement Report
Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled
Actavis Laboratories FL is recalling Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, distributed nationwide in the US. The recall was initiated on 24 Apr 2014 and the FDA has classified it as Class II.
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-1617-2014
- FDA event ID
- 69237
- Recalling firm
- Actavis Laboratories FL, Davie, FL
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2014
- FDA classified
- 30 Sep 2014
- Reported
- 8 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 24 Apr 2014 | Recall initiated by company | |
| 30 Sep 2014 | Classified by FDA | +159 days |
| 8 Oct 2014 | 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
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Product as listed by the FDA
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Which lots are affected?
Lot #: 660513A, Exp. 10/31/2014
Where was it sold?
Nationwide 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
1 other product · FDA event 69237This product is part of a recall event; the main page for the event is Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol | Actavis Laboratories FL | Other | Nationwide |
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|---|---|---|---|---|---|
| Drug | CLASS III | Ramipril Capsules, USP, 1.25 mg recalled by Actavis Laboratories, FL | Actavis Laboratories FL | Other | Nationwide |
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| Drug | CLASS III | Desmopressin Acetate Tablets, 0.1mg recalled by Actavis Laboratories, FL | Actavis Laboratories FL | Other | Nationwide |
| Drug | CLASS III | Cartia XT (diltiazem HCl extended-release capsules, USP) recalled | Actavis Laboratories FL | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol | Actavis Laboratories FL | Other | Nationwide |
Other Diclofenac recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diclofenac Sodium, Topical Gel, 3% tube recalledDiclofenac Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Diclofenac Sodium Topical Gel recalled by Cipla USADiclofenac Sodium | Cipla USA | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 2% w/w recalledDiclofenac Sodium | Alembic Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 1.5% w/w recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 1.5% w/w recalled | Teligent Pharma | Potency & Assay | Nationwide |