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Unrated Drug recall · FDA · Published March 20, 2023

RemedyRepack Simvastatin 10mg Tablets Recall: C G M P Deviations

RemedyRepack Inc. recalls Simvastatin 10mg tablets with specific NDC codes due to cGMP deviations. These prescription-only medications may have quality issues affecting safety.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0496-2023DrugRemedyRepack ›
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Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571
✎ GovInfoNow plain-language explainer

RemedyRepack Inc. is recalling Simvastatin 10 mg tablets in 30-count and 90-count bottles with specific NDC numbers because of manufacturing quality control issues. This recall affects people who have these prescription medications and could pose risks if the tablets are used without addressing the quality concerns. Read more at govinfonow.com/recall/33778-remedyrepack-simvastatin-10mg-tablets-recall-c-g-m-p-deviations.

Source Summary by GovInfoNow · govinfonow.com/recall/33778-remedyrepack-simvastatin-10mg-tablets-recall-c-g-m-p-deviations · Updated August 17, 2026 · FDA enforcement record: FDA #D-0496-2023

Cite this page

“RemedyRepack Simvastatin 10mg Tablets Recall: C G M P Deviations.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33778-remedyrepack-simvastatin-10mg-tablets-recall-c-g-m-p-deviations. Based on FDA recall #D-0496-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0496-2023%22&limit=1).

The FDA announced on March 20, 2023, that RemedyRepack Inc. is recalling Simvastatin 10 mg tablets due to current Good Manufacturing Practice (cGMP) deviations. The company initiated this voluntary Class II recall.

How to tell if you have it

  • Brand: RemedyRepack
  • Product: Simvastatin 10 mg tablets
  • Packaging: 30-count bottles (NDC 70518-0064-01) and 90-count bottles (NDC 70518-0064-00)
  • Lot codes: a) J0675206-011223, J0669260-121922, J0656820-103122, J0647161-091722, J0621491-052722, J0638138-080822, J0610887-041122; b) B1887315-100422, B1829906-083122, B1769715-071622, B1906605-101422, B1965118-111622
  • Distribution: Nationwide within the United States

The hazard

The recall is due to cGMP deviations. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show RemedyRePack Inc. has 35 other recalls on record since 2015-02-18. Other recent recalls of similar products include RemedyRepack Clindamycin Capsules Recall: CGMP Deviations Risk (2025-03-24) and RemedyRepack Carvedilol Tablets Recall: N-Nitroso Impurity Risk (2025-01-24). Other recent recalls of similar products include Wells Pharma Fentanyl Citrate Injectable Solution Recall: Cgmp Deviations (2026-04-01) and Shoolin Pharma Chem Sildenafil Recall: FDA Inspection Findings (2026-08-03).

How to tell if you have this one

Check for 30-count or 90-count bottles of Simvastatin 10 mg tablets with NDC numbers 70518-0064-01 or 70518-0064-00. Look for specific lot numbers and expiration dates listed in the recall notice.

  • Brand
    RemedyRepack
  • Category
    Drug
FDA recall event · 14 products

All 14 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    RemedyRepack distributed product to consignees nationwide within the United States
Recall numberProduct, codes & lotsQuantity
D-0490-2023Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03; Lot #: J0620431-052322, Exp. Date 05/31/233 bottles
D-0491-2023Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.; Lot #: a) J0679046-020123, Exp. Date 02/28/2024; J0669807-122122, Exp. Date 01/31/2024; J0662695-112222, Exp. Date 12/31/2023; J0654076-101822, J0654076-101822, Exp. Date 11/30/2023; J0642765-082922, Exp. Date 09/30/2023 Lot #: b) B1672408-050322, B1765902-071322, B1769634-071622, Exp. Date 04/30/2023; B1776907-072122, Exp. Date 09/30/2023; B1836636-090322, Exp. Date 11/30/2023; B1870344-092422, Exp. Date 01/31/2024; B1908452-101522, B1966455-111722, B2043099-010423, Exp. Date 05/31/2024a) 3,497 bottles, b) 729 bottles
D-0492-2023Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.; Lot #: a) J0665197-120522, Exp. Date 12/31/2023; J0642497-082722, Exp. Date 09/30/2023 J0638552-080922, Exp. Date 08/31/2023. Lot #: b) B1808799-081622, Exp. Date 05/31/2024a) 58 bottles, b) 6 bottles
D-0493-2023Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701; Lot #: a) J0674153-010923, Exp. Date 01/31/2024; J0649447-092822, Exp. Date 10/31/2023; J0644887-090722, Exp. Date 09/30/2023; J0627309-062222, Exp. Date 06/30/2023; J0622569-060222, Exp. Date 06/30/2023. b) B1646259-041222, Exp. Date 04/30/2023; B2032846-122722, Exp. Date 01/31/2025 B2018675-121722, Exp. Date 05/31/2025; B1708230-060122, B1709748-060122, Exp. Date 06/30/2023; B1692572-051822, Exp. Date 05/31/2023; B1803110-081122, Exp. Date 12/31/2024. c) B1820672-082422, B1814883-082022, Exp. Date 09/30/2024.a) 147 bottles, b)70 bottles, c) 3 bottles
D-0494-2023Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.; Lot #: B1789178-080122, Exp. Date 07/31/2023; B1675475-050522, Exp. Date 05/31/202317 bottles
D-0495-2023Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.; Lot #: J0668398-121422, Exp. Date 12/31/2023; J0661225-111522, J0654053-101822 Exp. Date 11/30/2023; J0646383-091422, Exp. Date 09/30/2023399 bottles
D-0496-2023Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701; Lot #: a) J0675206-011223, J0669260-121922, Exp. Date 01/31/2024; J0656820-103122, J0647161-091722, Exp. Date 09/30/2023 Exp. Date 11/30/2023; J0621491-052722, Exp. Date 06/30/2023; J0638138-080822, Exp. Date 08/31/2023, J0610887-041122, Exp. Date 04/30/2023. Lot # b) B1887315-100422, Exp. Date 02/28/2024; B1829906-083122, B1769715-071622, Exp. Date 09/30/2023; B1906605-101422, Exp. Date 02/28/2024; B1965118-111622, Exp. Date 02/28/2025.a) 1,262 bottles, b) 95 bottles
D-0497-2023Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00; Lot #: B1635780-040522, Exp. Date 04/30/202316 bottles
D-0498-2023Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.; Lot #: a) J0659819-110922, Exp. Date 11/30/2023; J0649932-093022, J0649917-093022 Exp. Date 10/31/2023, B2010060-121222, Exp. Date 03/31/24 Lot #: b) B1708575-060122, Exp. Date 05/31/2023; B1879236-092922, Exp. Date 12/31/20233,426 bottles
D-0499-2023Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00; Lot#: B1630017-040122, Exp. Date 04/30/20233 bottles
D-0500-2023Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00; Lot#: J0668398-121422, Exp. Date 12/31/2023; J0661225-111522, J0654053-101822 Exp. Date 11/30/2023; J0646383-091422, Exp. Date 09/30/2023132 bottles
D-0501-2023Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.; Lot#: a) NDC 70518-0375-03: J0674788-011123, Exp. Date 01/31/2024; J0664118-112922 J0664118-112922, Exp. Date 12/31/2023; J0653727-101722, Exp. Date 10/31/2023. NDC 70518-0375-01: B2057931-011223, Exp. Date 07/31/2025 b) Lot #: B2075815-012523, Exp. Date 09/30/2025; B2011634-121322, Exp. Date 07/31/2025 B1970205-112022, Exp. Date 06/30/2024; B1862598-092022, Exp. Date 03/31/2024; B2077226-012523, B2070444-012023, Exp. Date 07/31/2025.a) 399 bottles, b)445 bottles
D-0502-2023Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.; Lot # a): B2038806-123022, B2014185-121422, B1925528-102522, Exp. Date 07/31/2025. Lot #: b): B2080829-012823, B1938007-110222, B2038746-123022, Exp. Date 07/31/2025.a) 76 bottles, b)151 bottles
D-0503-2023Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701; Lot # a): J0656821-103122, Exp. Date 11/30/2023; J0638547-080922, Exp. Date 08/31/2023; J0633575-071822, Exp. Date 07/31/2023 Lot #: b): B1965081-111622, Exp. Date 03/31/2025; B1857922-091922, B1765298-071322, B1786319-072922, B1706842-053122, Exp. Date 04/30/2023; B2003311-120822, Exp. Date 04/30/2025; B1955679-111122, Exp. Date 02/28/2025; B1878942-092922, Exp. Date 11/30/2024; B1823203-082622. Exp. Date 10/31/2024; B1706843-053122, Exp. Date 05/31/2023—
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify your Simvastatin 10 mg tablets by checking the NDC code on the bottle and the lot number and expiration date.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “RemedyRepack distributed product to consignees nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

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

1. Firm started the recall: Mar 20, 202312. FDA classified it Class II: Mar 31, 202323. Published in FDA’s Enforcement Report: Apr 12, 202334. FDA terminated the recall: Oct 19, 202342023
  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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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-0496-2023 (March 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0496-2023 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