CLASS II ONGOING Drug recall · Reported 14 May 2025 · FDA Enforcement Report
Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack
RemedyRePack is recalling Clindamycin HCl Capsule, 300 mg, QTY: per, distributed in Florida, Pennsylvania, Virginia. The recall was initiated on 22 Apr 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-0411-2025
- FDA event ID
- 96764
- Recalling firm
- RemedyRePack, Indiana, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Apr 2025
- FDA classified
- 6 May 2025
- Reported
- 14 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antibiotics
Timeline
| 22 Apr 2025 | Recall initiated by company | |
| 6 May 2025 | Classified by FDA | +14 days |
| 14 May 2025 | Published in enforcement report | +8 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 - products manufactured in a shared facility with Ezetimibe tablets.
Product as listed by the FDA
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
Where it was distributed
Within U.S - PA, VA, FL.
Questions about this recall
Why was it recalled?
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Which lots are affected?
Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.
Where was it sold?
Within U.S - PA, VA, FL.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from RemedyRePack
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl, QTY recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Carvedilol, QTY: per Blister Pack ( blister cards) recalled | RemedyRepack | Nitrosamine Impurity | FL |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled | RemedyRepack | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Potassium Chloride Micro 10mEq recalled by RemedyRepack | RemedyRepack | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenazopyridine HCl, 100mg tablets recalled by RemedyRepack | RemedyRepack | Packaging Defects | PA |
Other Clindamycin recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 600 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |