CLASS II Drug recall · Reported 19 Feb 2014 · FDA Enforcement Report
Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled
Watson Laboratories Inc.-(Actavis) - Florida is recalling Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, distributed nationwide in the US. The recall was initiated on 20 Dec 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-1082-2014
- FDA event ID
- 67259
- Recalling firm
- Watson Laboratories Inc.-(Actavis) - Florida, Davie, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2013
- FDA classified
- 7 Feb 2014
- Reported
- 19 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 20 Dec 2013 | Recall initiated by company | |
| 7 Feb 2014 | Classified by FDA | +49 days |
| 19 Feb 2014 | Published in enforcement report | +12 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: Split tablets were found in the 12-month stability samples.
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
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Which lots are affected?
Lot# 605957A, Exp 09/14
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 3 Nov 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 Watson Laboratories Inc.-(Actavis) - Florida
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled | Watson Laboratories Inc.-(Actavis) - Florida | 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 |