The Recall Desk

Manufacturer

RemedyRepack Inc.

61 recalls in our database name RemedyRepack Inc. as the manufacturing or recalling firm.

What the numbers show

Total
61
Critical
1
Severe
13
Most recent
2025-05-14

Of the 61 recalls from RemedyRepack Inc. we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 13 (21%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 61

  • ModerateFDA (Drugs)·D-0411-2025·2025-05-14

    Clindamycin HCl Capsule 300 mg repackaged by RemedyRePack Inc.

    RemedyRePack Inc. is recalling Clindamycin HCl Capsule, 300 mg, due to current Good Manufacturing Practice (CGMP) deviations—the products were manufactured in a shared facility with Ezetimibe tablets.

    Product
    Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0378-2025·2025-04-30

    Clindamycin HCl 300 mg Capsule Recalled for CGMP Deviations

    RemedyRepack Inc. is recalling Clindamycin HCl 300 mg Capsules due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 1,858 30-count blister cards distributed in Pennsylvania.

    Product
    Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0217-2025·2025-02-12

    Carvedilol 25 mg tablets recalled due to N-nitroso impurity above limit

    RemedyRepack Inc. is recalling certain Carvedilol 25 mg tablets because testing found N-nitroso Carvedilol Impurity-1 exceeding FDA's acceptable limit due to manufacturing process deviations.

    Product
    Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0165-2025·2025-01-01

    Duloxetine delayed-release capsules recalled due to manufacturing impurity

    Duloxetine delayed-release 60mg capsules are being recalled nationwide due to N-nitroso-duloxetine impurity above recommended interim limits. Two lot numbers are affected: J0786744-061724 (blister cards) and B3002625-060524 (bottles).

    Product
    Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0611-2024·2024-07-24

    Potassium Chloride Extended Release Capsules Recalled for Dissolution Defect

    RemedyRepack Inc. is recalling Potassium Chloride Micro 10mEq K Extended Release Capsules because they fail to meet dissolution specifications, which could affect medication effectiveness.

    Product
    Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0549-2024·2024-06-19

    Phenazopyridine bottles recalled due to medication mix-up error

    RemedyRepack Inc. is recalling bottles labeled as Phenazopyridine HCl 100mg that actually contain Phenobarbital 16.2mg tablets. Eight bottles were distributed to one medical facility. Patients should not use these medications and must contact their healthcare provider.

    Product
    Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0489-2024·2024-05-15

    TraMADol HCl 50 mg Tablets Recalled for Foreign Baclofen Tablets

    RemedyRepack Inc. is recalling TraMADol HCl 50 mg tablets nationwide after a pharmacist discovered a baclofen tablet in a tramadol bottle. Taking the wrong medication poses serious health risks.

    Product
    TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0576-2023·2023-05-24

    Lorazepam Injection Vials Recalled Due to Manufacturing Quality Control Failures

    RemedyRepack Inc. is recalling 9,038 vials of Lorazepam Injection due to discontinuation of the manufacturer's quality control program. The product may not meet specified identity, strength, quality, and purity standards.

    Product
    LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0577-2023·2023-05-24

    Ketotifen Fumarate eye drops recalled due to manufacturing quality control deviations

    RemedyRepack Inc. is recalling Ketotifen Fumarate eye drops (NDC 70518-1142-00) distributed in Pennsylvania due to the manufacturer's discontinuation of quality assurance programs, which may have affected product identity, strength, and purity.

    Product
    Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0578-2023·2023-05-24

    Pyrazinamide 500 mg Tablets Recalled for Quality Program Discontinuation

    RemedyRepack Inc. is recalling Pyrazinamide 500 mg tablets because the original manufacturer discontinued the quality assurance program that would ensure the product meets identity, strength, quality, and purity standards.

    Product
    Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0496-2023·2023-04-12

    Simvastatin 10 mg Tablets Recalled for Manufacturing Practice Deviations

    RemedyRepack Inc. voluntarily recalled Simvastatin 10 mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lots distributed to consignees throughout the United States.

    Product
    Simvastatin 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0498-2023·2023-04-12

    Drug recall: Atorvastatin 20 mg tablets due to manufacturing process deviations

    RemedyRepack Inc. is recalling 3,426 bottles of Atorvastatin 20 mg tablets nationwide due to Good Manufacturing Practice (cGMP) deviations. The recall was initiated voluntarily by the manufacturer.

    Product
    Atorvastatin 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0492-2023·2023-04-12

    Doxazosin 2 mg tablets recalled for manufacturing practice deviations

    RemedyRepack Inc. is voluntarily recalling Doxazosin 2 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 30-count and 90-count bottles.

    Product
    Doxazosin 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0494-2023·2023-04-12

    Ropinirole 0.5 mg tablets recalled for manufacturing quality deviations

    RemedyRepack Inc. is recalling 17 bottles of Ropinirole 0.5 mg tablets due to manufacturing process deviations. The product was distributed nationwide within the United States.

    Product
    Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0501-2023·2023-04-12

    Rosuvastatin 10mg tablets recalled for manufacturing process deviations

    RemedyRepack Inc. is recalling Rosuvastatin 10mg tablets due to cGMP deviations in the manufacturing process. The recall affects 30-count and 90-count bottles distributed nationwide.

    Product
    Rosuvastatin 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2023·2023-04-12

    Drug Recall: Simvastatin tablets due to manufacturing deviations

    RemedyRepack Inc. is recalling Simvastatin 40 mg tablets nationwide due to manufacturing deviations. The voluntary recall was initiated in March 2023.

    Product
    Simvastatin 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0497-2023·2023-04-12

    Drug Recall: Tadalafil 5 mg Tablets Due to Manufacturing Deviations

    RemedyRepack Inc. recalled Tadalafil 5 mg tablets due to cGMP manufacturing process deviations. The recall affected 16 bottles distributed nationwide; no illnesses have been reported.

    Product
    Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2023·2023-04-12

    Drug Recall: Aripiprazole 5mg Tablets Due to Manufacturing Practice Deviations

    RemedyRepack Inc. is recalling Aripiprazole 5mg tablets (lot J0620431-052322) due to cGMP deviations affecting manufacturing practices. The voluntary recall includes 3 bottles distributed nationwide.

    Product
    Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0491-2023·2023-04-12

    Drug Recall: Atorvastatin 10 mg tablets due to manufacturing process violations

    RemedyRepack Inc. is recalling specific lots of Atorvastatin 10 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated March 20, 2023.

    Product
    Atorvastatin 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0502-2023·2023-04-12

    Rosuvastatin 40mg tablets recalled nationwide for manufacturing process deviations

    RemedyRepack is voluntarily recalling Rosuvastatin 40mg tablets due to manufacturing practice deviations. The recall affects specific lot numbers expiring 07/31/2025 distributed nationwide.

    Product
    Rosuvastatin 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0493-2023·2023-04-12

    Glimepiride 2 mg Tablets Recalled for Manufacturing Quality Deviations

    RemedyRepack Inc. is recalling Glimepiride 2 mg tablets distributed nationwide due to manufacturing quality deviations (cGMP violations). The recall affects 220 bottles across multiple lot numbers.

    Product
    Glimepiride 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0499-2023·2023-04-12

    Ropinirole 2mg Tablets Recalled for Manufacturing Practice Deviations

    RemedyRepack Inc. is recalling Ropinirole 2mg tablets due to manufacturing practice deviations. No illnesses have been reported.

    Product
    Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0495-2023·2023-04-12

    Drug Recall: Rosuvastatin 5mg Tablets for Manufacturing Deviations

    RemedyRepack Inc. is recalling 399 bottles of Rosuvastatin 5mg tablets nationwide due to manufacturing deviations. No illnesses have been reported.

    Product
    Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2023·2023-04-12

    Rosuvastatin 5mg Tablets Recalled Due to Manufacturing Deviations

    RemedyRepack Inc. voluntarily recalled 132 bottles of Rosuvastatin 5mg tablets nationwide due to current Good Manufacturing Practice deviations. No illnesses or injuries have been reported.

    Product
    Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0098-2023·2023-01-18

    Rifampin Capsules Recalled Due to Failed Quality Specifications

    RemedyRepack Inc. is recalling Rifampin Capsules, 300 mg, due to failed impurities and degradation specifications. The affected product was distributed to a single pharmacy account in Pennsylvania.

    Product
    Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
    Category
    Drug
    Distribution
    1 state