Exela Pharma Sciences LLC recalls Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by:
Exela Pharma Sciences recalls 75mg/0.2mg Diclo: tablets due to label mix-up with 50mg/0.2mg strength. No immediate danger but check your prescription bottles.
Lower-risk recall
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Contact the company & request your remedy
What happened, in plain English
Exela Pharma Sciences is recalling a specific prescription strength of Diclofenac Sodium and Misoprostol tablets due to a label mix-up. This means some bottles labeled as 75mg/0.2mg actually contain 50mg/0.2mg tablets. The recall does not pose a safety risk but requires verification of the correct strength. Read more at govinfonow.com/recall/40608-exela-diclofenac-misoprostol-tablets-recall-label-mix-up-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40608-exela-diclofenac-misoprostol-tablets-recall-label-mix-up-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0826-2018
Cite this page
“Exela Diclofenac Misoprostol Tablets Recall: Label Mix-Up Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40608-exela-diclofenac-misoprostol-tablets-recall-label-mix-up-risk. Based on FDA recall #D-0826-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0826-2018%22&limit=1).
Why it’s dangerous
The label mix-up means the tablets might be the wrong strength. This could lead to incorrect dosing if the patient takes the tablets as prescribed without verifying the strength. However, the recall does not indicate a safety risk beyond potential dosing errors.
Who’s affected
Prescription holders who have the 75 mg/0.2 mg labeled bottles. Those most at risk are patients taking this medication for conditions like arthritis or ulcers.
How to tell if you have this one
Check for the bottle labeled 'Diclofenac Sodium and Misoprostol 75 mg/0.2 mg' with NDC 42367-111-06. The lot number is GH70154, expiring December 2018.
- Brand
Exela Pharma Sciences- Category
Drug
What to do — step by step
Check Your Bottle
Verify the tablet strength on the label matches the intended 75 mg/0.2 mg strength.
Questions people ask
Is this recall dangerous?
No, the recall is for a label mix-up that could lead to incorrect dosing, but it does not pose a safety risk.
What should I do if I have this product?
Check the label to confirm the strength. If it's labeled 75 mg/0.2 mg but contains 50 mg/0.2 mg tablets, contact your doctor or pharmacist.
How can I tell if I have the recalled product?
Look for the bottle labeled 'Diclofenac Sodium and Misoprostol 75 mg/0.2 mg' with NDC 42367-111-06 and lot number GH70154.
Contact Exela Pharma Sciences
We’ve drafted a message you can send Exela Pharma Sciences to request your refund or repair — edit it as you like.
Subject: Recall D-0826-2018 — Exela Pharma Sciences Exela Pharma Sciences Hello, I own a Exela Pharma Sciences that is covered by recall D-0826-2018 from Exela Pharma Sciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0826-2018 (April 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0826-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.