CLASS II Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled
Actavis is recalling Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, distributed nationwide in the US. The recall was initiated on 22 Mar 2013 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-1060-2014
- FDA event ID
- 66380
- Recalling firm
- Actavis, Parsippany, NJ
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Mar 2013
- FDA classified
- 3 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 22 Mar 2013 | Recall initiated by company | |
| 3 Feb 2014 | Classified by FDA | +318 days |
| 12 Feb 2014 | Published in enforcement report | +9 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: Broken tablets
Product as listed by the FDA
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)
Where it was distributed
Nationwide
Questions about this recall
Is Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg recalled?
Yes. Actavis recalled Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg on 22 Mar 2013. The recall is Class II and its status is Terminated. Recall number D-1060-2014.
Why was it recalled?
Failed Tablet/Capsule Specifications: Broken tablets
Which lots are affected?
Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015
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 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 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.
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Other Diclofenac Sodium recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol | Actavis Laboratories, FL | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol | Actavis Laboratories, FL | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol | Actavis Laboratories, FL | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol | Watson Laboratories, Inc.-(Actavis) - Florida | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol | Watson Laboratories, Inc.-(Actavis) - Florida | Other | Nationwide |