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Unrated Drug recall · FDA · Published December 29, 2021

RemedyRePack Cefixime Capsules Recall: Failed Impurities Risk

RemedyRePack recalls Cefixime 400mg capsules with failed impurities/degradation specs. Rx-only products from specific lots and NDCs may pose safety risks.

🇺🇸 FDA recall #D-0360-2022DrugRemedyRePack ›
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Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571
✎ GovInfoNow plain-language explainer

What happened, in plain English

RemedyRePack is recalling certain Cefixime 400 mg capsules due to failed impurities or degradation specifications. This could potentially lead to unsafe drug content in the medication. Read more at govinfonow.com/recall/35412-remedyrepack-cefixime-capsules-recall-failed-impurities-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35412-remedyrepack-cefixime-capsules-recall-failed-impurities-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0360-2022

Cite this page

“RemedyRePack Cefixime Capsules Recall: Failed Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/35412-remedyrepack-cefixime-capsules-recall-failed-impurities-risk. Based on FDA recall #D-0360-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0360-2022%22&limit=1).

Why it’s dangerous

The capsules may contain impurities or have degraded beyond safe levels, which could affect the medication's safety and effectiveness. This issue occurs in specific batches with particular lot numbers and expiration dates.

Who’s affected

Prescription holders of the specific Cefixime 400 mg capsules with the listed NDC numbers and lot codes are affected. Patients taking these medications should be cautious.

How to tell if you have this one

Check for the product name 'Cefixime 400 mg capsule' with NDC numbers 70518-2749-02 or 70518-2749-03. Look for specific lot numbers and expiration dates listed in the recall notice.

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

What to do — step by step

  1. Check Product Details

    Verify your capsule's NDC number and lot code against the list provided in the recall notice.

Where it went and when

Where it was distributed

Distributed in Michigan and 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: yesMINew 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: “Product was distributed to two direct accounts in MI and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Michigan, Pennsylvania.

Recall timeline

FDA terminated this recall 3 months after the firm started it.

1. Firm started the recall: Dec 29, 202112. FDA classified it Class II: Jan 5, 202223. Published in FDA’s Enforcement Report: Jan 12, 202234. FDA terminated the recall: Apr 14, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-0360-2022 (December 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0360-2022 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