RemedyRepack Inc.
Complete recall history across all FDA and CPSC categories — 61 total recalls
RemedyRepack Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (61)
FDA drug safety enforcement actions by RemedyRepack Inc.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 22, 2025 | Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repack... | CGMP Deviations - products manufactured in a shared facility with Ezetimibe t... | Class II |
| Mar 24, 2025 | Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repack... | CGMP Deviations | Class II |
| Jan 24, 2025 | Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister car... | CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above t... | Class II |
| Dec 2, 2024 | Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70... | CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended ... | Class II |
| Jun 26, 2024 | Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count... | CGMP Deviations: Out of specification for dissolution | Class II |
| May 31, 2024 | Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: ... | Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg co... | Class II |
| May 2, 2024 | TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3... | Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist... | Class II |
| May 1, 2023 | LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn ... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that ... | Class II |
| May 1, 2023 | Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that ... | Class II |
| May 1, 2023 | Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, ... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that ... | Class II |
| Mar 20, 2023 | Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged ... | cGMP Deviations | Class II |
| Mar 20, 2023 | Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03... | cGMP Deviations | Class II |
| Mar 20, 2023 | Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... | cGMP Deviations | Class II |
| Mar 20, 2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... | cGMP Deviations | Class II |
| Mar 20, 2023 | Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) ... | cGMP Deviations | Class II |
| Mar 20, 2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... | cGMP Deviations | Class II |
| Mar 20, 2023 | Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01... | cGMP Deviations | Class II |
| Mar 20, 2023 | Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-0... | cGMP Deviations | Class II |
| Mar 20, 2023 | Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepac... | cGMP Deviations | Class II |
| Mar 20, 2023 | Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03)... | cGMP Deviations | Class II |
| Mar 20, 2023 | Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-0... | cGMP Deviations | Class II |
| Mar 20, 2023 | Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01... | cGMP Deviations | Class II |
| Mar 20, 2023 | Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by... | cGMP Deviations | Class II |
| Mar 20, 2023 | Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01... | cGMP Deviations | Class II |
| Dec 20, 2022 | Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma,... | Failed Impurities/Degradation specifications | Class II |
| Dec 5, 2022 | Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 2315... | Subpotent Drug: repackaged product was recalled by the manufacturer for subpo... | Class II |
| Sep 15, 2022 | Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, ... | Presence of Foreign Substance: Foreign material (metal piece) embedded in one... | Class II |
| May 4, 2022 | Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repac... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II |
| May 2, 2022 | Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged ND... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II |
| May 2, 2022 | Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC ... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II |
| Apr 6, 2022 | Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1)... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II |
| Dec 30, 2021 | Metformin 750 mg Extended Release NDC # 70518-2920-00 | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess ... | Class II |
| Dec 29, 2021 | Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b... | Failed Impurities/Degradation Specifications | Class II |
| Aug 17, 2021 | Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pen... | A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Table... | Class II |
| Oct 11, 2020 | Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx o... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above th... | Class II |
| Jun 29, 2020 | Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repacka... | FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution ... | Class II |
| Dec 27, 2019 | Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repacka... | Presence of Particulate Matter: Medication relabeled at facility was recalled... | Class I |
| Dec 11, 2019 | Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repac... | CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylam... | Class II |
| Aug 5, 2019 | Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lu... | Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-201... | Class II |
| Apr 22, 2019 | Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobu... | Class II |
| Mar 14, 2019 | Losartan 50mg Tablet, 30 count each blister card. | CGMP Deviations; Detection of trace amounts of an unexpected impurity found i... | Class II |
| Nov 7, 2018 | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60... | Cross contamination with other products: Product is being recalled due to the... | Class III |
| Oct 26, 2018 | Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifes... | Failed pH Specifications: High Out-of-Specification results for pH were obtai... | Class III |
| Aug 24, 2018 | Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in c... | CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or c... | Class II |
| Aug 20, 2018 | Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles ... | CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or c... | Class II |
| Aug 10, 2018 | Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, Reme... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Aug 10, 2018 | Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Aug 10, 2018 | Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Jul 17, 2018 | Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
| Jul 17, 2018 | Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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