Skip to content
Unrated Drug recall · FDA · Published March 24, 2025

RemedyRepack Clindamycin Capsules Recall: CGMP Deviations Risk

RemedyRepack Inc. recalls 300 mg Clindamycin HCl capsules due to CGMP deviations. Affected lots expire by Dec 2025. Consumers should contact the company for details.

🇺🇸 FDA recall #D-0378-2025DrugRemedyRepack ›
Take action

Contact the company

Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571
✎ GovInfoNow plain-language explainer

What happened, in plain English

RemedyRepack Inc. is recalling 300 mg Clindamycin HCl capsules that were repackaged by their company. The recall is due to CGMP deviations, which means the product may not meet quality standards. This could affect safety for people using prescription antibiotics. Read more at govinfonow.com/recall/32173-remedyrepack-clindamycin-capsules-recall-cgmp-deviations-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32173-remedyrepack-clindamycin-capsules-recall-cgmp-deviations-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0378-2025

Cite this page

“RemedyRepack Clindamycin Capsules Recall: CGMP Deviations Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32173-remedyrepack-clindamycin-capsules-recall-cgmp-deviations-risk. Based on FDA recall #D-0378-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0378-2025%22&limit=1).

Why it’s dangerous

CGMP deviations refer to failures in manufacturing quality control processes. This could mean the capsules do not meet the required safety and purity standards for prescription medication. However, the exact risk level is not specified in the recall notice.

Who’s affected

Prescription users of Clindamycin HCl 300 mg capsules repackaged by RemedyRepack Inc. in Indiana, PA. Those with the specific lot numbers listed in the recall are most at risk.

How to tell if you have this one

Check the product label for the NDC code 70518-3772-00. Look for lot numbers J0826722-121624 (expiring Dec 2025), J0820365-111324 (expiring Nov 2025), or J0814691-101624 (expiring Oct 2025).

  • Brand
    RemedyRepack
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the NDC code 70518-3772-00 and specific lot numbers listed in the recall.

Where it went and when

Where it was distributed

Distributed in Pennsylvania.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “PA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Pennsylvania.

Recall timeline

FDA published this recall 37 days after the firm started it.

1. Firm started the recall: Mar 24, 202512. FDA classified it Class II: Apr 18, 202523. Published in FDA’s Enforcement Report: Apr 30, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest drug recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0378-2025 (March 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0378-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA