CLASS III Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report
Fentanyl 1,500 mcg/ syringe, Injection for Intravenous Use recalled
SCA Pharmaceuticals is recalling Fentanyl 1,500 mcg/ syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, distributed nationwide in the US. The recall was initiated on 24 Feb 2023 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-0363-2023
- FDA event ID
- 91774
- Recalling firm
- SCA Pharmaceuticals, Windsor, CT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Feb 2023
- FDA classified
- 28 Feb 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 24 Feb 2023 | Recall initiated by company | |
| 28 Feb 2023 | Classified by FDA | +4 days |
| 8 Mar 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
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
Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
Where it was distributed
Nationwide in the US.
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot # 1222043351, exp. date 03/29/2023 1222043387, exp. date 04/05/2023 1222043352, exp. date 04/05/2023 1222043463, exp. date 04/06/2023 1223043922, exp. date 05/04/2023
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 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 SCA Pharmaceuticals
All 166| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL 200 mcg/, Bupivacaine HCl recalled by SCA Pharmaceuticals | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL 2,500 mcg/ Injection (Concentration = 50 mcg/mL) recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | SUCcinylcholine Chloride 200 mg/ Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride recalled | SCA Pharmaceuticals | Sterility | Nationwide |
Other Fentanyl 1 recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL 1,250 mcg/ Injection recalled by SCA Pharmaceuticals | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Fentanyl 1,000 mcg/ml Intrathecal Solution recalled | The Compounding Pharmacy of America | Sterility | Nationwide |