Clindamycin HCl 300 mg Capsule Recalled for CGMP Deviations
RemedyRepack Inc. is recalling Clindamycin HCl 300 mg Capsules due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 1,858 30-count blister cards distributed in Pennsylvania.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text contains no reports of illness, injury, or adverse health outcomes—the hazard is CGMP process-related rather than a known pathogen or harmful contamination. Per the rubric, manufacturing deviations without reported harm and no high-risk pathogen involvement fall within the Moderate category.
Plain-English summary
RemedyRepack Inc., located in Indiana, Pennsylvania, is voluntarily recalling Clindamycin HCl 300 mg Capsules (NDC 70518-3772-00) due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves three lots: J0826722-121624 (Exp. 12/31/2025), J0820365-111324 (Exp. 11/30/2025), and J0814691-101624 (Exp. 10/31/2025), with a total of approximately 1,858 30-count blister cards affected.
The recalled product was distributed in Pennsylvania. Patients taking Clindamycin HCl from the affected lots should contact their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacists should stop dispensing the affected lots immediately and quarantine remaining inventory.
The recalled product
- Product
- Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Antibiotic / Capsule
- Hazard
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · RemedyRepack Inc.
See all →- ModerateClindamycin HCl Capsule 300 mg repackaged by RemedyRePack Inc.
FDA (Drugs) · 2025-05-14
- HighCarvedilol 25 mg tablets recalled due to N-nitroso impurity above limit
FDA (Drugs) · 2025-02-12
- HighDuloxetine delayed-release capsules recalled due to manufacturing impurity
FDA (Drugs) · 2025-01-01
- HighPotassium Chloride Extended Release Capsules Recalled for Dissolution Defect
FDA (Drugs) · 2024-07-24
- HighPhenazopyridine bottles recalled due to medication mix-up error
FDA (Drugs) · 2024-06-19
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- HighShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate USP Recalled for CGMP Deviations Noted During FDA Inspection
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate Recall Due to CGMP Deviations
FDA (Drugs) · 2026-08-19