Clindamycin HCl recall
FDA recall D-0378-2025 · initiated Mar 24, 2025
RemedyRepack Inc. recalled Clindamycin HCl in Mar 2025 — an FDA Class II recall (D-0378-2025) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
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: 1,858 30-count blister cards
Details
- Product
- Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
- Recalling company
- RemedyRepack Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- PA
- Initiated
- Mar 24, 2025
- FDA report date
- Apr 30, 2025
Frequently asked
- Was Clindamycin HCl recalled?
- RemedyRepack Inc. recalled Clindamycin HCl in Mar 2025 — an FDA Class II recall (D-0378-2025) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Clindamycin HCl recalled?
- Per the FDA enforcement record, the reason for recall D-0378-2025 was: CGMP Deviations
- Is a recalled Clindamycin HCl 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 are affected?
- Distributed: PA. The recall covers these lots — Lot J0826722-121624 Exp. 12/31/2025 Lot J0820365-111324 Exp. 11/30/2025 Lot J0814691-101624 Exp. 10/31/2025. 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-0378-2025.