Diclofenac Sodium And Misoprostol

Diclofenac Sodium And Misoprostol recalls: 6 FDA reports

Recalls involving Diclofenac Sodium And Misoprostol. What was wrong with each batch, and how the FDA graded the risk.

6Reports
0Class I
0Ongoing
2014-12-03Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II6

By year reported

YearReports
20131
20145
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufacture

D-0258-2015  ·  Class II  ·  reported 2014-12-03  ·  Terminated

Why it was recalled
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Product
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 went
U.S. Nationwide including Puerto Rico.
How much
5,451 Bottles

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufacture

D-1616-2014  ·  Class II  ·  reported 2014-10-08  ·  Terminated

Why it was recalled
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Product
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 went
Nationwide and Puerto Rico
How much
36,538 bottles

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufacture

D-1617-2014  ·  Class II  ·  reported 2014-10-08  ·  Terminated

Why it was recalled
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Product
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 went
Nationwide and Puerto Rico
How much
6,041 bottles

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufacture

D-1082-2014  ·  Class II  ·  reported 2014-02-19  ·  Terminated

Why it was recalled
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Product
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 went
Nationwide
How much
5987 bottles

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laborat

D-1060-2014  ·  Class II  ·  reported 2014-02-12  ·  Terminated

Why it was recalled
Failed Tablet/Capsule Specifications: Broken tablets
Product
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 went
Nationwide
How much
6,540 bottles

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured

D-817-2013  ·  Class II  ·  reported 2013-07-31  ·  Terminated

Why it was recalled
Failed Tablet/Capsule Specifications: Broken tablets
Product
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
Where it went
Nationwide
How much
392,400 tablets
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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