Medications & Supplements/Prescription Drugs

RemedyRepack Various Prescription Drugs Recalled for Manufacturing Deviations

Agency Publication Date: April 1, 2023

Summary

RemedyRepack Inc. is recalling approximately 9,435 bottles of various prescription medications, including common treatments like Atorvastatin (Lipitor), Rosuvastatin (Crestor), and Simvastatin (Zocor), because they were processed using methods that deviated from current Good Manufacturing Practices (cGMP). The recall affects drugs used to treat conditions ranging from high cholesterol and blood pressure to diabetes and Parkinson's disease. While no injuries or illnesses have been reported to date, the manufacturer is taking this voluntary action to ensure consumer safety.

Risk

Deviations in manufacturing processes can lead to inconsistencies in the quality, safety, or potency of a drug. This could result in a patient receiving an ineffective dose or a medication that does not meet federal safety standards for pharmaceutical production.

What You Should Do

This recall affects multiple prescription medications repackaged by RemedyRepack Inc., including Aripiprazole, Atorvastatin, Doxazosin, Glimepiride, Ropinirole, Rosuvastatin, Simvastatin, and Tadalafil in various strengths and bottle sizes.
Identify your medication by checking the repackager information on the bottle label for 'RemedyRepack Inc.' then verify the drug name, lot number, and expiration date. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Aripiprazole (30-count bottle)

Variants: 5 mg, Tablet

Lot Numbers:

J0620431-052322 (Exp. Date 05/31/23)

NDC:

70518-2921-03

Product: Atorvastatin (30-count and 90-count bottles)

Variants: 10 mg, Tablet

Lot Numbers:

J0679046-020123 (Exp. Date 02/28/2024)

J0669807-122122 (Exp. Date 01/31/2024)

J0662695-112222 (Exp. Date 12/31/2023)

J0654076-101822 (Exp. Date 11/30/2023)

J0642765-082922 (Exp. Date 09/30/2023)

B1672408-050322 (Exp. Date 04/30/2023)

B1765902-071322 (Exp. Date 04/30/2023)

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 (Exp. Date 05/31/2024)

B1966455-111722 (Exp. Date 05/31/2024)

B2043099-010423 (Exp. Date 05/31/2024)

NDC:

70518-1946-00

70518-1946-01

Product: Doxazosin (30-count and 90-count bottles)

Variants: 2 mg, Tablet

Lot Numbers:

J0665197-120522 (Exp. Date 12/31/2023)

J0642497-082722 (Exp. Date 09/30/2023)

J0638552-080922 (Exp. Date 08/31/2023)

B1808799-081622 (Exp. Date 05/31/2024)

NDC:

70518-1560-00

70518-1560-01

Product: Glimepiride (30, 90, and 180-count bottles)

Variants: 2 mg, Tablet

Lot Numbers:

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)

B1646259-041222 (Exp. Date 04/30/2023)

B2032846-122722 (Exp. Date 01/31/2025)

B2018675-121722 (Exp. Date 05/31/2025)

B1708230-060122 (Exp. Date 06/30/2023)

B1709748-060122 (Exp. Date 06/30/2023)

B1692572-051822 (Exp. Date 05/31/2023)

B1803110-081122 (Exp. Date 12/31/2024)

B1820672-082422 (Exp. Date 09/30/2024)

B1814883-082022 (Exp. Date 09/30/2024)

NDC:

70518-0405-03

70518-0405-00

70518-0405-02

Product: Ropinirole (90-count bottle)

Variants: 0.5 mg, Tablet

Lot Numbers:

B1789178-080122 (Exp. Date 07/31/2023)

B1675475-050522 (Exp. Date 05/31/2023)

NDC:

70518-2439-00

Product: Rosuvastatin (30-count bottle)

Variants: 5 mg, Tablet

Lot Numbers:

J0668398-121422 (Exp. Date 12/31/2023)

J0661225-111522 (Exp. Date 11/30/2023)

J0654053-101822 (Exp. Date 11/30/2023)

J0646383-091422 (Exp. Date 09/30/2023)

NDC:

70518-3519-00

Product: Simvastatin (30-count and 90-count bottles)

Variants: 10 mg, Tablet

Lot Numbers:

J0675206-011223 (Exp. Date 01/31/2024)

J0669260-121922 (Exp. Date 01/31/2024)

J0656820-103122 (Exp. Date 11/30/2023)

J0647161-091722 (Exp. Date 09/30/2023)

J0621491-052722 (Exp. Date 06/30/2023)

J0638138-080822 (Exp. Date 08/31/2023)

J0610887-041122 (Exp. Date 04/30/2023)

B1887315-100422 (Exp. Date 02/28/2024)

B1829906-083122 (Exp. Date 09/30/2023)

B1769715-071622 (Exp. Date 09/30/2023)

B1906605-101422 (Exp. Date 02/28/2024)

B1965118-111622 (Exp. Date 02/28/2025)

NDC:

70518-0064-01

70518-0064-00

Product: Tadalafil (30-count bottle)

Variants: 5 mg, Tablet

Lot Numbers:

B1635780-040522 (Exp. Date 04/30/2023)

NDC:

70518-2972-00

Product: Atorvastatin (30-count and 90-count bottles)

Variants: 20 mg, Tablet

Lot Numbers:

J0659819-110922 (Exp. Date 11/30/2023)

J0649932-093022 (Exp. Date 10/31/2023)

J0649917-093022 (Exp. Date 10/31/2023)

B2010060-121222 (Exp. Date 03/31/24)

B1708575-060122 (Exp. Date 05/31/2023)

B1879236-092922 (Exp. Date 12/31/2023)

NDC:

70518-1977-00

70518-1977-01

Product: Ropinirole (180-count bottle)

Variants: 2 mg, Tablet

Lot Numbers:

B1630017-040122 (Exp. Date 04/30/2023)

NDC:

70518-2750-00

Product: Rosuvastatin (30-count and 90-count bottles)

Variants: 10 mg, Tablet

Lot Numbers:

J0674788-011123 (Exp. Date 01/31/2024)

J0664118-112922 (Exp. Date 12/31/2023)

J0653727-101722 (Exp. Date 10/31/2023)

B2057931-011223 (Exp. Date 07/31/2025)

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 (Exp. Date 07/31/2025)

B2070444-012023 (Exp. Date 07/31/2025)

NDC:

70518-0375-03

70518-0375-01

70518-0375-00

Product: Rosuvastatin (45-count and 90-count bottles)

Variants: 40 mg, Tablet

Lot Numbers:

B2038806-123022 (Exp. Date 07/31/2025)

B2014185-121422 (Exp. Date 07/31/2025)

B1925528-102522 (Exp. Date 07/31/2025)

B2080829-012823 (Exp. Date 07/31/2025)

B1938007-110222 (Exp. Date 07/31/2025)

B2038746-123022 (Exp. Date 07/31/2025)

NDC:

70518-1311-01

70518-0484-00

Product: Simvastatin (30-count and 90-count bottles)

Variants: 40 mg, Tablet

Lot Numbers:

J0656821-103122 (Exp. Date 11/30/2023)

J0638547-080922 (Exp. Date 08/31/2023)

J0633575-071822 (Exp. Date 07/31/2023)

B1965081-111622 (Exp. Date 03/31/2025)

B1857922-091922 (Exp. Date 04/30/2023)

B1765298-071322 (Exp. Date 04/30/2023)

B1786319-072922 (Exp. Date 04/30/2023)

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)

NDC:

70518-0060-01

70518-0060-00

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91980

Status: Resolved

Manufacturer: RemedyRepack Inc.

Sold By: Pharmacies; Consignees nationwide

Manufactured In: United States

Units Affected: 13 products (3 bottles; a) 3,497 bottles, b) 729 bottles; a) 58 bottles, b) 6 bottles; a) 147 bottles, b)70 bottles, c) 3 bottles; 17 bottles; 399 bottles; a) 1,262 bottles, b) 95 bottles; 16 bottles; 3,426 bottles; 3 bottles; 132 bottles; a) 399 bottles, b)445 bottles; a) 76 bottles, b)151 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects multiple prescription medications repackaged by RemedyRepack Inc., including Aripiprazole, Atorvastatin, Doxazosin, Glimepiride, Ropinirole, Rosuvastatin, Simvastatin, and Tadalafil in various strengths and bottle sizes.

Identify your medication by checking the repackager information on the bottle label for 'RemedyRepack Inc.' then verify the drug name, lot number, and expiration date. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Aripiprazole (30-count bottle)

Variants: 5 mg, Tablet

Lot Numbers:

J0620431-052322 (Exp. Date 05/31/23)

NDC:

70518-2921-03

Product: Atorvastatin (30-count and 90-count bottles)

Variants: 10 mg, Tablet

Lot Numbers:

J0679046-020123 (Exp. Date 02/28/2024)

J0669807-122122 (Exp. Date 01/31/2024)

J0662695-112222 (Exp. Date 12/31/2023)

J0654076-101822 (Exp. Date 11/30/2023)

J0642765-082922 (Exp. Date 09/30/2023)

B1672408-050322 (Exp. Date 04/30/2023)

B1765902-071322 (Exp. Date 04/30/2023)

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 (Exp. Date 05/31/2024)

B1966455-111722 (Exp. Date 05/31/2024)

B2043099-010423 (Exp. Date 05/31/2024)

NDC:

70518-1946-00

70518-1946-01

Product: Doxazosin (30-count and 90-count bottles)

Variants: 2 mg, Tablet

Lot Numbers:

J0665197-120522 (Exp. Date 12/31/2023)

J0642497-082722 (Exp. Date 09/30/2023)

J0638552-080922 (Exp. Date 08/31/2023)

B1808799-081622 (Exp. Date 05/31/2024)

NDC:

70518-1560-00

70518-1560-01

Product: Glimepiride (30, 90, and 180-count bottles)

Variants: 2 mg, Tablet

Lot Numbers:

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)

B1646259-041222 (Exp. Date 04/30/2023)

B2032846-122722 (Exp. Date 01/31/2025)

B2018675-121722 (Exp. Date 05/31/2025)

B1708230-060122 (Exp. Date 06/30/2023)

B1709748-060122 (Exp. Date 06/30/2023)

B1692572-051822 (Exp. Date 05/31/2023)

B1803110-081122 (Exp. Date 12/31/2024)

B1820672-082422 (Exp. Date 09/30/2024)

B1814883-082022 (Exp. Date 09/30/2024)

NDC:

70518-0405-03

70518-0405-00

70518-0405-02

Product: Ropinirole (90-count bottle)

Variants: 0.5 mg, Tablet

Lot Numbers:

B1789178-080122 (Exp. Date 07/31/2023)

B1675475-050522 (Exp. Date 05/31/2023)

NDC:

70518-2439-00

Product: Rosuvastatin (30-count bottle)

Variants: 5 mg, Tablet

Lot Numbers:

J0668398-121422 (Exp. Date 12/31/2023)

J0661225-111522 (Exp. Date 11/30/2023)

J0654053-101822 (Exp. Date 11/30/2023)

J0646383-091422 (Exp. Date 09/30/2023)

NDC:

70518-3519-00

Product: Simvastatin (30-count and 90-count bottles)

Variants: 10 mg, Tablet

Lot Numbers:

J0675206-011223 (Exp. Date 01/31/2024)

J0669260-121922 (Exp. Date 01/31/2024)

J0656820-103122 (Exp. Date 11/30/2023)

J0647161-091722 (Exp. Date 09/30/2023)

J0621491-052722 (Exp. Date 06/30/2023)

J0638138-080822 (Exp. Date 08/31/2023)

J0610887-041122 (Exp. Date 04/30/2023)

B1887315-100422 (Exp. Date 02/28/2024)

B1829906-083122 (Exp. Date 09/30/2023)

B1769715-071622 (Exp. Date 09/30/2023)

B1906605-101422 (Exp. Date 02/28/2024)

B1965118-111622 (Exp. Date 02/28/2025)

NDC:

70518-0064-01

70518-0064-00

Product: Tadalafil (30-count bottle)

Variants: 5 mg, Tablet

Lot Numbers:

B1635780-040522 (Exp. Date 04/30/2023)

NDC:

70518-2972-00

Product: Atorvastatin (30-count and 90-count bottles)

Variants: 20 mg, Tablet

Lot Numbers:

J0659819-110922 (Exp. Date 11/30/2023)

J0649932-093022 (Exp. Date 10/31/2023)

J0649917-093022 (Exp. Date 10/31/2023)

B2010060-121222 (Exp. Date 03/31/24)

B1708575-060122 (Exp. Date 05/31/2023)

B1879236-092922 (Exp. Date 12/31/2023)

NDC:

70518-1977-00

70518-1977-01

Product: Ropinirole (180-count bottle)

Variants: 2 mg, Tablet

Lot Numbers:

B1630017-040122 (Exp. Date 04/30/2023)

NDC:

70518-2750-00

Product: Rosuvastatin (30-count and 90-count bottles)

Variants: 10 mg, Tablet

Lot Numbers:

J0674788-011123 (Exp. Date 01/31/2024)

J0664118-112922 (Exp. Date 12/31/2023)

J0653727-101722 (Exp. Date 10/31/2023)

B2057931-011223 (Exp. Date 07/31/2025)

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 (Exp. Date 07/31/2025)

B2070444-012023 (Exp. Date 07/31/2025)

NDC:

70518-0375-03

70518-0375-01

70518-0375-00

Product: Rosuvastatin (45-count and 90-count bottles)

Variants: 40 mg, Tablet

Lot Numbers:

B2038806-123022 (Exp. Date 07/31/2025)

B2014185-121422 (Exp. Date 07/31/2025)

B1925528-102522 (Exp. Date 07/31/2025)

B2080829-012823 (Exp. Date 07/31/2025)

B1938007-110222 (Exp. Date 07/31/2025)

B2038746-123022 (Exp. Date 07/31/2025)

NDC:

70518-1311-01

70518-0484-00

Product: Simvastatin (30-count and 90-count bottles)

Variants: 40 mg, Tablet

Lot Numbers:

J0656821-103122 (Exp. Date 11/30/2023)

J0638547-080922 (Exp. Date 08/31/2023)

J0633575-071822 (Exp. Date 07/31/2023)

B1965081-111622 (Exp. Date 03/31/2025)

B1857922-091922 (Exp. Date 04/30/2023)

B1765298-071322 (Exp. Date 04/30/2023)

B1786319-072922 (Exp. Date 04/30/2023)

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)

NDC:

70518-0060-01

70518-0060-00

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91980

Status: Resolved

Manufacturer: RemedyRepack Inc.

Sold By: Pharmacies; Consignees nationwide

Manufactured In: United States

Distributed To: Nationwide