CLASS II Drug recall · Reported 10 Apr 2019 · FDA Enforcement Report
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient recalled
Johnson Matthey is recalling Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, distributed nationwide in the US. The recall was initiated on 5 Mar 2018 and the FDA has classified it as Class II.
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-1077-2019
- FDA event ID
- 82298
- Recalling firm
- Johnson Matthey, West Deptford, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2018
- FDA classified
- 3 Apr 2019
- Reported
- 10 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 5 Mar 2018 | Recall initiated by company | |
| 3 Apr 2019 | Classified by FDA | +394 days |
| 10 Apr 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
Where it was distributed
Nationwide in the US
Questions about this recall
Is Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient recalled?
Yes. Johnson Matthey recalled Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient on 5 Mar 2018. The recall is Class II and its status is Terminated. Recall number D-1077-2019.
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Which lots are affected?
Lot# B1414-160809, Retest Date AUG 2021
Where was it sold?
Nationwide in the US
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Oxaliplatin Active Pharmaceutical Ingredient recalled by Johnson Matthey | Johnson Matthey | Foreign Material | Nationwide |
| Drug | CLASS II | Cisplatin Active Pharmaceutical Ingredient recalled by Johnson Matthey | Johnson Matthey | Foreign Material | Nationwide |
| Drug | CLASS II | Fentanyl Citrate Active Pharmaceutical Ingredient recalled | Johnson Matthey | Foreign Material | Nationwide |
| Drug | CLASS III | Remifentanil HCl active pharmaceutical ingredient (API) recalled | Johnson Matthey | Foreign Material | Nationwide |
Other Morphine recalls
All 27| 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 | Morphine Sulfate Extended-Release Tablets 15 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |