CLASS II Drug recall · Reported 9 Aug 2023 · FDA Enforcement Report
fentaNYL, 5000 mcg/, (50 mcg/mL) recalled by Central Admixture Pharmacy
Central Admixture Pharmacy Services is recalling fentaNYL, 5000 mcg/, (50 mcg/mL), distributed nationwide in the US. The recall was initiated on 17 Jul 2023 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-1051-2023
- FDA event ID
- 92752
- Recalling firm
- Central Admixture Pharmacy Services, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2023
- FDA classified
- 3 Aug 2023
- Reported
- 9 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 17 Jul 2023 | Recall initiated by company | |
| 3 Aug 2023 | Classified by FDA | +17 days |
| 9 Aug 2023 | 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
Lack of assurance of sterility: Lack of validation data for sanitization cycles
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
fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
Where it was distributed
Nationwide in the USA
Questions about this recall
Is fentaNYL, 5000 mcg/, (50 mcg/mL) recalled?
Yes. Central Admixture Pharmacy Services recalled fentaNYL, 5000 mcg/, (50 mcg/mL) on 17 Jul 2023. The recall is Class II and its status is Terminated. Recall number D-1051-2023.
Why was it recalled?
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Which lots are affected?
Lot: 17-273074, Exp. 8/28/2023; 17-273772, Exp. 9/7/2023.
Where was it sold?
Nationwide in the USA
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.