RemedyRepack recalls
17 official recalls and safety alerts involving RemedyRepack since 2022-01, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with RemedyRepack or the relevant agency.
- 2025-05-14
USRemedyRePack Inc. recalls Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#:…
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
- 2025-04-30
- US
- 2025-02-12
- US
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 07430, Repackaged…
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
- 2025-01-01
- US
RemedyRepack Inc. recalls Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
- 2024-07-24
- US
RemedyRepack Inc. recalls Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430,…
CGMP Deviations: Out of specification for dissolution
- 2024-06-19
- US
RemedyRepack Inc. recalls Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source…
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- 2024-05-15
- US
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 70518-3824-02; (a)…
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
- 2023-05-24
- US
RemedyRepack Inc. recalls Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc.,…
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.
- 2023-04-12
- US
RemedyRepack Inc. recalls Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only,…
cGMP Deviations
FDA · DrugRemedyRepack Inc.RemedyRepack distributed product to consignees nationwide within the United…Official notice → - 2023-01-18
- US
RemedyRepack Inc. recalls Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged…
Failed Impurities/Degradation specifications
- 2022-12-14
- US
RemedyRepack Inc. recalls Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ…
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
FDA · DrugRemedyRepack Inc.Product was distributed to two different customers in MI.Official notice → - 2022-09-21
- US
RemedyRepack Inc. recalls Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA.…
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
- 2022-06-01
- US
RemedyRepack Inc. recalls Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- US
RemedyRepack Inc. recalls Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-05-04
- US
RemedyRepack Inc. recalls Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- 2022-01-19
- US
RemedyRepack Inc. recalls Metformin 750 mg Extended Release NDC # 70518-2920-00
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- 2022-01-12
- US
RemedyRepack Inc. recalls Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG:…
Failed Impurities/Degradation Specifications
FDA · DrugRemedyRepack Inc.Product was distributed to two direct accounts in MI and PA.Official notice →