Clindamycin HCl Capsule recall
FDA recall D-0411-2025 · initiated Apr 22, 2025
RemedyRePack Inc. recalled Clindamycin HCl Capsule in Apr 2025 — an FDA Class II recall (D-0411-2025) because CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 23 bottles/30 count- 690 capsules
Details
- Product
- Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
- Recalling company
- RemedyRePack Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Within U.S - PA, VA, FL.
- Initiated
- Apr 22, 2025
- FDA report date
- May 14, 2025
Frequently asked
- Was Clindamycin HCl Capsule recalled?
- RemedyRePack Inc. recalled Clindamycin HCl Capsule in Apr 2025 — an FDA Class II recall (D-0411-2025) because CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Clindamycin HCl Capsule recalled?
- Per the FDA enforcement record, the reason for recall D-0411-2025 was: CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
- Is a recalled Clindamycin HCl Capsule dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Clindamycin HCl Capsule are affected?
- Distributed: Within U.S - PA, VA, FL.. The recall covers these lots — Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0411-2025.