Class III · Low risk
Alprostadil Injection USP 500 mcg/mL
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Alprostadil Container Description: Amber color bottle
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Alprostadil Container Description: Amber color bottle
Drug: Alprostadil
- Recalling firm
- Aspen Biopharma Labs Pvt., Ltd.
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0261-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Alprostadil recalls
See all
Class II · Moderate risk
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60…
Lack of assurance of sterility.
Class II · Moderate risk
PGE-3 Alprostadil 150 mcg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10…
Lack of assurance of sterility.
Other recalls by Aspen Biopharma Labs Pvt., Ltd.
All 2025 recalls
Class II · Moderate risk
Voriconazole Container Description: voriconazole The product…
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
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