FDA Drugs recall ·
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only… recall
- Recall number
- D-0411-2025
- Date
- (initiated April 22, 2025)
- Company / brand
- RemedyRepack Inc.
625 Kolter Dr Ste 4, Indiana, PA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 23 bottles/30 count- 690 capsules
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
Why was it recalled?
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
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#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.
Distribution
Within U.S - PA, VA, FL.
States: Florida Pennsylvania Virginia
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-0411-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.