Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01

Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impuri…

Recall #: D-1214-2018
Affected scope: 4716 bottle
Initiated: August 23, 2018

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

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Lupin Somerset recalled Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured… - a low-severity action.

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured… was recalled by Lupin Somerset in September 26, 2018. Reason: Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled du…. Check the official notice for the remedy. Verify recall #D-1214-2018 with the FDA Drug before acting.

The recall

Lupin Somerset issued this low-severity FDA Drug recall-Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled du….

Low
severity level: Class III
classification: September 26, 2018
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1214-2018 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 low severity.

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

Product description

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01

Reason for recall

Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	D-1214-2018
Date reported	September 26, 2018
Date initiated	August 23, 2018
Recalling firm	Lupin Somerset
Firm location	Somerset, NJ
Affected scope	4716 bottle
Distribution	U.S.A. Nationwide

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-1214-2018) and product description against the item you own. Search the archive
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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? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on September 26, 2018. Severity: Low. Recall number: D-1214-2018.

Where was the recalled product distributed? ▼

Distribution: U.S.A. Nationwide.

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

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Low), closest by report date among other firms and states.

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This recall: FDA Drug, reported September 26, 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