Latanoprost medication recalled due to manufacturing practice deviations
Aspen Biopharma Labs is recalling Latanoprost medication due to manufacturing practice deviations. The voluntary recall affects product distributed to distributors in Hong Kong and Florida.
What this means for you
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: FDA Class II recall for manufacturing practice deviations represents a risk-of-harm drug product. Per the rubric, this scores 3 because it is not accompanied by hospitalization or injury reports.
Plain-English summary
Aspen Biopharma Labs Pvt., Ltd. is recalling Latanoprost (NDC# 82187-1002-1) supplied in amber-colored bottles. The recalled product contains 150 grams and is identified by two lot numbers: HALAC0010123 with expiration date December 2026, and HALAC0050923 with expiration date August 2027.
The manufacturer voluntarily initiated the recall in response to deviations from Current Good Manufacturing Practice (CGMP) standards. The product was distributed to three wholesale accounts: one distributor located in Hong Kong and two distributors located in Florida.
Patients and healthcare providers who possess this medication should contact their pharmacist or healthcare provider for further guidance. The recall began on February 7, 2025.
The recalled product
- Product
- Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
- Manufacturer
- Aspen Biopharma Labs Pvt., Ltd.
- Category
- Drug
- Hazard
- manufacturing-deviation
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 (3)
- Lot Numbers: HALAC0010123
- exp. date Dec-2026 HALAC0050923
- exp. date Aug-2027
Distribution
Distribution scope not specified by the agency.
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