The Recall Desk
ModerateFDA (Drugs)·D-0378-2025·Announced 2025-04-30

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
  • cgmp-deviation

Distribution

Distributed in 1 state:

  • PA

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