Recall archive
35 recalls · page 1 of 2
Reported May 14, 2025
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRePack Inc.
Matched: Brand · Product · Product details — CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
FDA (openFDA drug enforcement)
Reported Apr 30, 2025
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product · Product details — CGMP Deviations
FDA (openFDA drug enforcement)
Reported Feb 12, 2025
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
FDA (openFDA drug enforcement)
Reported Jan 1, 2025
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
FDA (openFDA drug enforcement)
Reported Jul 24, 2024
Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — CGMP Deviations: Out of specification for dissolution
FDA (openFDA drug enforcement)
Reported Jun 19, 2024
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product · Product details — Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
FDA (openFDA drug enforcement)
Reported May 15, 2024
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count…
FDA (openFDA drug enforcement)
Reported May 24, 2023
LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 12, 2023
Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product · Product details — cGMP Deviations
13 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 18, 2023
Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — Failed Impurities/Degradation specifications
FDA (openFDA drug enforcement)
Reported Dec 14, 2022
Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
FDA (openFDA drug enforcement)
Reported Sep 21, 2022
Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product · Product details — Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
FDA (openFDA drug enforcement)
Reported Jun 1, 2022
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand — CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
2 more products in this recall
FDA (openFDA drug enforcement)
Reported May 4, 2022
Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand — CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
FDA (openFDA drug enforcement)
Reported Jan 19, 2022
Metformin 750 mg Extended Release NDC # 70518-2920-00
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand — CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
FDA (openFDA drug enforcement)
Reported Jan 12, 2022
Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand — Failed Impurities/Degradation Specifications
FDA (openFDA drug enforcement)
Reported Sep 1, 2021
Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
FDA (openFDA drug enforcement)
Reported Nov 4, 2020
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product · Product details — CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
FDA (openFDA drug enforcement)
Reported Jul 22, 2020
Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product · Product details — FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
FDA (openFDA drug enforcement)
Reported Mar 25, 2020
Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand — Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was…
FDA (openFDA drug enforcement)
Reported Feb 19, 2020
Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA…
High riskUsing this product could cause serious injury, illness or death — stop using it now.RemedyRepack Inc.
Matched: Brand · Product · Product details — Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine…
FDA (openFDA drug enforcement)
Reported Jan 29, 2020
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand — CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
FDA (openFDA drug enforcement)
Reported May 8, 2019
Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
FDA (openFDA drug enforcement)
Reported Apr 17, 2019
Losartan 50mg Tablet, 30 count each blister card.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand — CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric…
FDA (openFDA drug enforcement)
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