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Use caution Drug recall · FDA · Published April 22, 2025

RemedyRePack Recalls Clindamycin Capsules Due to CGMP Deviations

RemedyRePack Inc. recalls specific lots of Clindamycin HCl Capsules, 300 mg due to current Good Manufacturing Practice deviations in a shared facility.

🇺🇸 FDA recall #D-0411-2025DrugRemedyRePack ›
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Recalling firmRemedyRePack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571
✎ GovInfoNow plain-language explainer

RemedyRePack Inc. is recalling Clindamycin HCl Capsules, 300 mg, repackaged at their Indiana, PA facility. The recall addresses Current Good Manufacturing Practice (CGMP) deviations because the products were manufactured in a shared facility with Ezetimibe tablets. The record does not specify the exact nature of the contamination or cross-contamination risk beyond this manufacturing deviation. Read more at govinfonow.com/recall/32122-remedyrepack-recalls-clindamycin-capsules-due-to-cgmp-deviations.

Source Summary by GovInfoNow · govinfonow.com/recall/32122-remedyrepack-recalls-clindamycin-capsules-due-to-cgmp-deviations · Updated October 9, 2026 · FDA enforcement record: FDA #D-0411-2025

Cite this page

“RemedyRePack Recalls Clindamycin Capsules Due to CGMP Deviations.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32122-remedyrepack-recalls-clindamycin-capsules-due-to-cgmp-deviations. Based on FDA recall #D-0411-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0411-2025%22&limit=1).

The FDA announced on April 22, 2025, that RemedyRePack Inc. is recalling Clindamycin HCl Capsules due to CGMP deviations involving a shared facility with Ezetimibe tablets. The agency issued recall number D-0411-2025 for the Class II voluntary recall.

How to tell if you have it

  • Brand: RemedyRePack
  • Product: Clindamycin HCl Capsules, 300 mg, 30 capsules per bottle
  • NDC#: 70518-3772-02
  • Lot codes: B3698036-033125, B3688703-032625
  • Expiration date: 07/31/2026
  • Distribution: Pennsylvania, Virginia, Florida

The hazard

The recall stems from CGMP deviations because the products were manufactured in a shared facility with Ezetimibe tablets. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show RemedyRePack Inc. has 35 other recalls on record since February 18, 2015. Recent brand recalls include Clindamycin Capsules on March 24, 2025, Carvedilol Tablets on January 24, 2025, and Duloxetine 60mg capsules on December 2, 2024. Other recent recalls of similar products include Baxter Clindamycin Injection Recall (August 6, 2026) and Baxter Clindamycin Injection Recall (August 6, 2026).

How to tell if you have this one

Check your medication bottle for NDC# 70518-3772-02 and Lot numbers B3698036-033125 or B3688703-032625. The expiration date is 07/31/2026, and the product contains 30 capsules per bottle.

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

What to do — step by step

  1. Contact Your Pharmacist

    Reach out to your pharmacy or healthcare provider immediately to verify if you have the recalled lots and to discuss alternative treatment options.

  2. Do Not Take Recalled Lots

    If you possess medication with the identified lot numbers, do not consume it until you have received guidance from your healthcare provider.

Where it went and when

Where it was distributed

Distributed in 3 states.

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: yesVAMaryland: 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: yesFL

FDA distribution: “Within U.S - PA, VA, FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Pennsylvania, Virginia.

Recall timeline

FDA published this recall 22 days after the firm started it.

1. Firm started the recall: Apr 22, 202512. FDA classified it Class II: May 6, 202523. Published in FDA’s Enforcement Report: May 14, 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.

✎ GovInfoNow

Questions people ask

What is the NDC number for the recalled product?

The National Drug Code (NDC) is 70518-3772-02.

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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-0411-2025 (April 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0411-2025 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 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