Drug Recall: Alprostadil Affected by Manufacturing Practice Deviations
Alprostadil 3.0 gm is being recalled due to manufacturing practice deviations. Limited distribution affects product with lot number HAALC0020922 (expiration August 2025).
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II pharmaceutical recall involving CGMP deviations in the manufacturing process. While no illnesses or injuries have been reported, CGMP deviations in drug manufacturing represent a meaningful risk of harm to product quality, purity, or potency.
Plain-English summary
Aspen Biopharma Labs is voluntarily recalling Alprostadil (3.0 gm) in amber bottles due to Good Manufacturing Practice (CGMP) deviations discovered in the manufacturing process. The affected lot number is HAALC0020922, with an expiration date of August 2025.
The recall was initiated on February 7, 2025, and classified by the FDA as a Class II recall on March 9, 2025. The product was distributed to 3 distributors: one in Hong Kong and two accounts in Florida.
No illnesses or injuries have been reported in connection with this product. Patients who have this medication are advised to consult their healthcare provider or pharmacist about whether to continue use or obtain a replacement from an alternative source.
The recalled product
- Product
- Alprostadil Container Description: Amber color bottle
- Manufacturer
- Aspen Biopharma Labs Pvt., Ltd.
- Category
- Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: HAALC0020922 exp. date AUG-2025
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 6 recalled by Aspen Biopharma Labs Pvt., Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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