CLASS II ONGOING Drug recall · Reported 19 Mar 2025 · FDA Enforcement Report
Bimatoprost recalled by Aspen Biopharma Labs Pvt
Aspen Biopharma Labs Pvt is recalling Bimatoprost, distributed in Florida. The recall was initiated on 7 Feb 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0260-2025
- FDA event ID
- 96209
- Recalling firm
- Aspen Biopharma Labs Pvt, Medchal Malkajgiri
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Feb 2025
- FDA classified
- 9 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 7 Feb 2025 | Recall initiated by company | |
| 9 Mar 2025 | Classified by FDA | +30 days |
| 19 Mar 2025 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Where it was distributed
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Questions about this recall
Is Bimatoprost recalled?
Yes. Aspen Biopharma Labs Pvt recalled Bimatoprost on 7 Feb 2025. The recall is Class II and its status is Ongoing. Recall number D-0260-2025.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot Numbers: HABTC0020123, exp. date Dec-2026 HABTC0050623, exp. date May-2027 HABTC0091023, exp. date Sep-2028
Where was it sold?
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.