Remedyrepack recalls
Remedyrepack appears in 61 official U.S. recall notices indexed by RecallRadar, most recently on 2025-05-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 61 |
|---|---|
| Published | 2015-04-15 to 2025-05-14 |
| By agency | FDA Drug (61) |
| By classification | Class II (58), Class III (2), Class I (1) |
| By status | terminated (56), ongoing (5) |
| Distribution named in notices | AK, CA, FL, LA, MI, MN, NY, OK, PA, SC, US, VA |
Recalls
- Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
FDA Drug · Class II · 2025-05-14 · Remedyrepack
Reason: CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets. - Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
FDA Drug · Class II · 2025-04-30 · Remedyrepack
Reason: CGMP Deviations - Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged b…
FDA Drug · Class II · 2025-02-12 · Remedyrepack
Reason: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. - 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…
FDA Drug · Class II · 2025-01-01 · Remedyrepack
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. - Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repac…
FDA Drug · Class II · 2024-07-24 · Remedyrepack
Reason: CGMP Deviations: Out of specification for dissolution - Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source ND…
FDA Drug · Class II · 2024-06-19 · Remedyrepack
Reason: Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg. - TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00
FDA Drug · Class II · 2024-05-15 · Remedyrepack
Reason: 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 - Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., India…
FDA Drug · Class II · 2023-05-24 · Remedyrepack
Reason: 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. - Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01
FDA Drug · Class II · 2023-05-24 · Remedyrepack
Reason: 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. - LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana…
FDA Drug · Class II · 2023-05-24 · Remedyrepack
Reason: 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. - 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 bott…
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - 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, Repack…
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - 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, Repack…
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - 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…
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - 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, Repac…
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repac…
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - 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: Re…
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - 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, Repack…
FDA Drug · Class II · 2023-04-12 · Remedyrepack
Reason: cGMP Deviations - Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged b…
FDA Drug · Class II · 2023-01-18 · Remedyrepack
Reason: Failed Impurities/Degradation specifications - Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01
FDA Drug · Class II · 2022-12-14 · Remedyrepack
Reason: Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. - Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Ori…
FDA Drug · Class II · 2022-09-21 · Remedyrepack
Reason: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. - Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
FDA Drug · Class II · 2022-06-01 · Remedyrepack
Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
FDA Drug · Class II · 2022-06-01 · Remedyrepack
Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. - Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
FDA Drug · Class II · 2022-06-01 · Remedyrepack
Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. - 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 b…
FDA Drug · Class II · 2022-05-04 · Remedyrepack
Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. - Metformin 750 mg Extended Release NDC # 70518-2920-00
FDA Drug · Class II · 2022-01-19 · Remedyrepack
Reason: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. - 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: Asce…
FDA Drug · Class II · 2022-01-12 · Remedyrepack
Reason: Failed Impurities/Degradation Specifications - Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepa…
FDA Drug · Class II · 2021-09-01 · Remedyrepack
Reason: A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles. - Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2…
FDA Drug · Class II · 2020-11-04 · Remedyrepack
Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) - Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-0…
FDA Drug · Class II · 2020-07-22 · Remedyrepack
Reason: FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing. - Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original ND…
FDA Drug · Class II · 2020-03-25 · Remedyrepack
Reason: 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 observed in the 500 s count product bottle. - Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00
FDA Drug · Class I · 2020-02-19 · Remedyrepack
Reason: Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples. - Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
FDA Drug · Class II · 2020-01-29 · Remedyrepack
Reason: CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels. - Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc
FDA Drug · Class II · 2019-05-08 · Remedyrepack
Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million. - Losartan 50mg Tablet, 30 count each blister card
FDA Drug · Class II · 2019-04-17 · Remedyrepack
Reason: CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA). - Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repacka…
FDA Drug · Class III · 2018-12-05 · Remedyrepack
Reason: Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine). - Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
FDA Drug · Class III · 2018-11-21 · Remedyrepack
Reason: Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing. - Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518…
FDA Drug · Class II · 2018-10-31 · Remedyrepack
Reason: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient. - Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 3827…
FDA Drug · Class II · 2018-09-05 · Remedyrepack
Reason: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient. - Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701,…
FDA Drug · Class II · 2018-08-22 · Remedyrepack
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701,…
FDA Drug · Class II · 2018-08-22 · Remedyrepack
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701,…
FDA Drug · Class II · 2018-08-22 · Remedyrepack
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
FDA Drug · Class II · 2018-08-08 · Remedyrepack
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
FDA Drug · Class II · 2018-08-08 · Remedyrepack
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.