FDA Drugs recall ·
Alprostadil Container Description: Amber color bottle recall
- Recall number
- D-0261-2025
- Date
- (initiated February 7, 2025)
- Company / brand
- Aspen Biopharma Labs Pvt., Ltd.
Plot No 10, Biotech Park Phase-II, Medchal Malkajgiri, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3.0 gm
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Alprostadil Container Description: Amber color bottle
Why was it recalled?
CGMP Deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Numbers: HAALC0020922 exp. date AUG-2025
Distribution
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
States: Florida
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0261-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.