CLASS III Drug recall · Reported 1 May 2019 · FDA Enforcement Report
Morphine Sulfate Extended-Release Tablets, 15 mg recalled
Lupin Somerset is recalling Morphine Sulfate Extended-Release Tablets, 15 mg, distributed nationwide in the US. The recall was initiated on 10 Apr 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1243-2019
- FDA event ID
- 82581
- Recalling firm
- Lupin Somerset, Somerset, NJ
- Brand
- Morphine Sulfate
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Apr 2019
- FDA classified
- 25 Apr 2019
- Reported
- 1 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 10 Apr 2019 | Recall initiated by company | |
| 25 Apr 2019 | Classified by FDA | +15 days |
| 1 May 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot#: S700220, Exp. Apr 30 2019; S700604, Exp. July 31 2019; S800326, Exp. Mar 31 2020
Where was it sold?
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 82581This product is part of a recall event; the main page for the event is Morphine Sulfate Extended-Release Tablets, 60 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Morphine Sulfate Extended-Release Tablets, 60 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide | |
| CLASS III | Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide | |
| CLASS III | Morphine Sulfate Extended-Release Tablets, 200 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide | |
| CLASS III | Morphine Sulfate Extended-Release Tablets, 30 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide |
More recalls from Lupin Somerset
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Morphine Sulfate Extended-Release Tablets, 30 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS III | Morphine Sulfate Extended-Release Tablets, 200 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS III | Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS III | Morphine Sulfate Extended-Release Tablets, 60 mg recalledMorphine Sulfate | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS II | Gavilyte-N, PEG-3350, Sodium chloride recalled by Lupin SomersetGavilyte-n | Lupin Somerset | Other | Nationwide |
Other Morphine recalls
All 147| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine Sulfate | Winder Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets 30 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200 | Hikma Pharmaceuticals USA | Other | Nationwide |