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Lower risk Drug recall · FDA · Published August 17, 2021

RemedyRepack Carvedilol 25mg Bottles Contain Extra Paroxetine Tablets

RemedyRepack Inc. recalls 180-count Carvedilol 25mg bottles (Rx only) that accidentally contain Paroxetine tablets due to repackaging error. This could cause unintended medication interactions.

🇺🇸 FDA recall #D-0754-2021DrugRemedyRepack ›
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Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571
✎ GovInfoNow plain-language explainer

RemedyRepack Inc. recalled 180-count Carvedilol 25mg bottles that accidentally contain Paroxetine tablets. This could cause unintended medication interactions if taken with other medications. Read more at govinfonow.com/recall/35933-remedyrepack-carvedilol-25mg-bottles-contain-extra-paroxetine-tablets.

Source Summary by GovInfoNow · govinfonow.com/recall/35933-remedyrepack-carvedilol-25mg-bottles-contain-extra-paroxetine-tablets · Updated August 18, 2026 · FDA enforcement record: FDA #D-0754-2021

Cite this page

“RemedyRepack Carvedilol 25mg Bottles Contain Extra Paroxetine Tablets.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35933-remedyrepack-carvedilol-25mg-bottles-contain-extra-paroxetine-tablets. Based on FDA recall #D-0754-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0754-2021%22&limit=1).

The FDA announced on August 17, 2021, that RemedyRepack Inc. is recalling Carvedilol 25 mg tablets due to the presence of Paroxetine Tablets, 40 mg. The agency classified this as a Class II recall.

How to tell if you have it

  • Brand: RemedyRepack
  • Product: Carvedilol 25 mg, 180-count bottle
  • NDC: 68382-0095-05 (Manufacturer Zydus Pharm) and 70518-1826-01 (Repackager)
  • Lot #: B1273286-071521
  • Expiration: 07/31/2022
  • Quantity: 4 bottles
  • Distribution: Two medical facilities in VA and FL

The hazard

A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. The product was repackaged into 180 count bottles.

Context

GovInfoNow's records show RemedyRePack Inc. has 35 other recalls on record since February 18, 2015. Other recent recalls of similar products include RemedyRepack Clindamycin Capsules Recall (March 24, 2025), RemedyRepack Carvedilol Tablets Recall (January 24, 2025), and Granules Pharmaceuticals Trazodone 50mg Recall (January 26, 2026).

How to tell if you have this one

Check for the 180-count bottle labeled 'Carvedilol 25 mg, Rx only' with NDC 68382-0095-05. The product was repackaged by RemedyRepack Inc. in Indiana, PA.

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

What to do — step by step

  1. Check Product Label

    Look for the 180-count bottle with NDC 68382-0095-05 and the lot number B1273286-071521.

Where it went and when

Where it was distributed

Distributed in Florida and Virginia.

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: not listedPANew 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: “Product was distributed to two medical facilities in VA and FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Virginia.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

1. Firm started the recall: Aug 17, 202112. FDA classified it Class II: Aug 20, 202123. Published in FDA’s Enforcement Report: Sep 1, 202134. FDA terminated the recall: Mar 9, 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.

✎ GovInfoNow

Questions people ask

Do I need to stop using this product?

No, but you should check if you have the recalled product and contact your doctor if you take other medications that interact with paroxetine.

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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-0754-2021 (August 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0754-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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