RemedyRePack Recalls
61 recalls on record · April 15, 2015 to May 14, 2025 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 14, 2025DrugsFDA
RemedyRePack Inc. recalls Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 157
Hazard: CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
April 30, 2025DrugsFDA
RemedyRepack Inc. recalls Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 157
Hazard: CGMP Deviations
February 12, 2025DrugsFDA
RemedyRepack Inc. recalls Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ
Hazard: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
January 1, 2025DrugsFDA
RemedyRepack Inc. recalls Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 7051
Hazard: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
July 24, 2024DrugsFDA
RemedyRepack Inc. recalls Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahw
Hazard: CGMP Deviations: Out of specification for dissolution
June 19, 2024DrugsFDA
RemedyRepack Inc. recalls Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518
Hazard: Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
May 15, 2024DrugsFDA
RemedyRepack Inc. recalls TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 7051
Hazard: Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
May 24, 2023DrugsFDA
RemedyRepack Inc. recalls Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-25
Hazard: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
May 24, 2023DrugsFDA
RemedyRepack Inc. recalls Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: Remed
Hazard: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
May 24, 2023DrugsFDA
RemedyRepack Inc. recalls LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: Remedy
Hazard: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-0
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-0
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-0
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-0
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, N
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) a
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx on
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-
Hazard: cGMP Deviations
April 12, 2023DrugsFDA
RemedyRepack Inc. recalls Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921
Hazard: cGMP Deviations
January 18, 2023DrugsFDA
RemedyRepack Inc. recalls Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-06
Hazard: Failed Impurities/Degradation specifications
December 14, 2022DrugsFDA
RemedyRepack Inc. recalls Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc.,
Hazard: Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
September 21, 2022DrugsFDA
RemedyRepack Inc. recalls Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack I
Hazard: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
June 1, 2022DrugsFDA
RemedyRepack Inc. recalls Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
June 1, 2022DrugsFDA
RemedyRepack Inc. recalls Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
June 1, 2022DrugsFDA
RemedyRepack Inc. recalls Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits