Bimatoprost drug recalled for manufacturing quality deviations
Aspen Biopharma Labs is recalling Bimatoprost due to manufacturing practice deviations. The recall is voluntary and affects product distributed to wholesalers.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary recall due to CGMP deviations with no reported illnesses, injuries, or specific identified hazard. Per the severity rubric, voluntary precautionary recalls without reported harm are classified as Moderate.
Plain-English summary
Aspen Biopharma Labs Pvt., Ltd. is voluntarily recalling Bimatoprost (NDC 82187-1001-1) in 400-gram quantities due to deviations from Current Good Manufacturing Practice (CGMP) standards. The FDA classified this recall as Class II, which indicates potential for serious adverse health consequences, though no illnesses or injuries have been reported.
The affected product was distributed to three wholesale accounts: one distributor in Hong Kong and two accounts in Florida. The affected lot numbers are HABTC0020123 (expires December 2026), HABTC0050623 (expires May 2027), and HABTC0091023 (expires September 2028).
Consumers and healthcare providers who have received or are using the affected product should stop use and consult their healthcare provider with any questions or concerns. The recall was voluntarily initiated by the manufacturer on February 7, 2025.
The recalled product
- Product
- Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
- 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 (4)
- Lot Numbers: HABTC0020123
- exp. date Dec-2026 HABTC0050623
- exp. date May-2027 HABTC0091023
- exp. date Sep-2028
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27