Recall events
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Event 82581
Event summary
Timeline bucket April 10, 2019
Product types Drug
Classifications Class III
Statuses Terminated
Recalling firm wording LUPIN SOMERSET
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
5 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 5
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01
D-1243-2019
Recall number D-1243-2019
Initiated April 10, 2019
Classification Class III
Status Terminated
Quantity 17,328 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications
Code information Lot#: S700220, Exp. Apr 30 2019; S700604, Exp. July 31 2019; S800326, Exp. Mar 31 2020
Distribution pattern Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13966]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 5
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-541-01
D-1244-2019
Recall number D-1244-2019
Initiated April 10, 2019
Classification Class III
Status Terminated
Quantity 15,320 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications
Code information Lot#: S700221, Exp. Apr 30 2019; S700605, Exp. July 31 2019; S800232, Exp. Feb 29 2020.
Distribution pattern Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14001]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 5
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-01
D-1245-2019
Recall number D-1245-2019
Initiated April 10, 2019
Classification Class III
Status Terminated
Quantity 10,284 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications
Code information Lot#: S700222 Exp. Apr 30 2019 ; S800233 Exp, Feb 29 2020
Distribution pattern Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13997]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 5
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543-01
D-1246-2019
Recall number D-1246-2019
Initiated April 10, 2019
Classification Class III
Status Terminated
Quantity 3,444 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications
Code information Lot#: S700223 Exp. Apr 30 2019; S800467, Exp. Mar 31 2020.
Distribution pattern Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13956]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 5
Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01
D-1247-2019
Recall number D-1247-2019
Initiated April 10, 2019
Classification Class III
Status Terminated
Quantity 324 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications
Code information Lot#: S700224 Exp. Apr 30 2019; S800469 Exp. Mar 31 2020
Distribution pattern Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[13962]
FDA event record
· Exact recall-number query on openFDA
