CLASS III Drug recall · Reported 26 Sep 2018 · FDA Enforcement Report
Morphine Sulfate Extended-Release Tablets, 30 mg recalled
Lupin Somerset is recalling Morphine Sulfate Extended-Release Tablets, 30 mg, distributed nationwide in the US. The recall was initiated on 23 Aug 2018 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-1214-2018
- FDA event ID
- 80874
- Recalling firm
- Lupin Somerset, Somerset, NJ
- Brand
- Morphine Sulfate
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Aug 2018
- FDA classified
- 27 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 23 Aug 2018 | Recall initiated by company | |
| 26 Sep 2018 | Published in enforcement report | +34 days |
| 27 Sep 2018 | Classified by FDA | +1 day |
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: 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.
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, 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
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot# S800232, Exp 2/20
Where was it sold?
U.S.A. Nationwide
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.
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, 15 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 |
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 |