CLASS II Drug recall · Reported 2 Oct 2019 · FDA Enforcement Report
Fentanyl Citrate Active Pharmaceutical Ingredient recalled
Johnson Matthey is recalling Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical, distributed nationwide in the US. The recall was initiated on 29 Aug 2019 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-1880-2019
- FDA event ID
- 83457
- Recalling firm
- Johnson Matthey, West Deptford, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Aug 2019
- FDA classified
- 25 Sep 2019
- Reported
- 2 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 29 Aug 2019 | Recall initiated by company | |
| 25 Sep 2019 | Classified by FDA | +27 days |
| 2 Oct 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
cGMP Deviations: Potential glass contamination
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
cGMP Deviations: Potential glass contamination
Which lots are affected?
Lot #: B0030-180101, B0030-180102, Exp. Feb 2023
Where was it sold?
Nationwide within 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 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 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
2 other products · FDA event 83457| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cisplatin Active Pharmaceutical Ingredient recalled by Johnson Matthey | Johnson Matthey | Foreign Material | Nationwide | |
| CLASS II | Oxaliplatin Active Pharmaceutical Ingredient recalled by Johnson Matthey | Johnson Matthey | Foreign Material | Nationwide |
More recalls from Johnson Matthey
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 III | Remifentanil HCl active pharmaceutical ingredient (API) recalled | Johnson Matthey | Potency & Assay | Nationwide |
| Drug | CLASS II | Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient recalled | Johnson Matthey | Sterility | Nationwide |