Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.

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.

Recall #: D-0826-2018
Affected scope: 5256 bottles
Initiated: April 20, 2018

Compiled from official public sources by the publisher. · Updated September 2026

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Exela Pharma Sciences LLC recalled Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, … - a moderate-severity action.

Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, … was recalled by Exela Pharma Sciences LLC in May 30, 2018. Reason: Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac…. Check the official notice for the remedy. Verify recall #D-0826-2018 with the FDA Drug before acting.

The recall

Exela Pharma Sciences LLC issued this moderate-severity FDA Drug recall-Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac….

Moderate
severity level: Class II
classification: May 30, 2018
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0826-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 1 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.

Reason for 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.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	D-0826-2018
Date reported	May 30, 2018
Date initiated	April 20, 2018
Recalling firm	Exela Pharma Sciences LLC
Firm location	Lenoir, NC
Affected scope	5256 bottles
Distribution	Nationwide in the USA and Puerto Rico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0826-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on May 30, 2018. Severity: Moderate. Recall number: D-0826-2018.

Where was the recalled product distributed? ▼

Distribution: Nationwide in the USA and Puerto Rico.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Drug, reported May 30, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026