Indiana, PA, United States
RemedyRepack Inc. recalls
31 recalls recorded since 2018, most recently on 22 April 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls31
Ongoing (FDA)4
Terminated or completed27
Class I (FDA)1
Ongoing Class II Drugs
- Recall started
- 22 April 2025
- Reason
- CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
- Distribution
- Within U.S - PA, VA, FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0411-2025
- Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
Ongoing Class II Drugs
- Recall started
- 24 March 2025
- Reason
- CGMP Deviations
- Distribution
- PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0378-2025
- Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
Terminated Class II Drugs
- Recall started
- 24 January 2025
- Terminated
- 17 July 2025
- Reason
- CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
- Distribution
- FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0217-2025
- Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
Ongoing Class II Drugs
- Recall started
- 2 December 2024
- Reason
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0165-2025
- 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, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged b
Terminated Class II Drugs
- Recall started
- 26 June 2024
- Terminated
- 31 January 2025
- Reason
- CGMP Deviations: Out of specification for dissolution
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0611-2024
- Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03
Terminated Class II Drugs
- Recall started
- 31 May 2024
- Terminated
- 1 July 2024
- Reason
- Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Distribution
- Product was distributed to one medical facility.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0549-2024
- Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA
Terminated Class II Drugs
- Recall started
- 2 May 2024
- Terminated
- 9 September 2024
- 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
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0489-2024
- 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) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plai
Ongoing Class II Drugs
- Recall started
- 1 May 2023
- Terminated
- 21 June 2023
- 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.
- Distribution
- Product was distrituded to three direct account in PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0577-2023, D-0578-2023, D-0576-2023
- Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
- Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 617
- LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00
Terminated Class II Drugs
- Recall started
- 20 March 2023
- Terminated
- 19 October 2023
- Reason
- cGMP Deviations
- Distribution
- RemedyRepack distributed product to consignees nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0496-2023, D-0499-2023, D-0503-2023, D-0491-2023, D-0493-2023, D-0497-2023, D-0498-2023, D-0502-2023, D-0495-2023, D-0492-2023, D-0500-2023, D-0490-2023 and 2 more
- 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, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
- Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
- 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, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
- 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, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
- 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 bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 1
- Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
- 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, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
- Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
- and 6 more product lines
Terminated Class II Drugs
- Recall started
- 20 December 2022
- Terminated
- 3 March 2023
- Reason
- Failed Impurities/Degradation specifications
- Distribution
- Product was distributed to one account in PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0098-2023
- Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
Terminated Class II Drugs
- Recall started
- 5 December 2022
- Terminated
- 3 February 2023
- Reason
- Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
- Distribution
- Product was distributed to two different customers in MI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0077-2023
- Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-0
Terminated Class II Drugs
- Recall started
- 15 September 2022
- Terminated
- 16 November 2022
- Reason
- Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
- Distribution
- Distributed to two direct accounts in PA and AK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1538-2022
- Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00
Terminated Class II Drugs
- Recall started
- 4 May 2022
- Terminated
- 2 September 2022
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Distribution
- Recalled product was distributed to Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0885-2022
- Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Terminated Class II Drugs
- Recall started
- 2 May 2022
- Terminated
- 2 September 2022
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Distribution
- Product was distributed to FL, SC and VA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0886-2022, D-0887-2022
- Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
- Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Terminated Class II Drugs
- Recall started
- 6 April 2022
- Terminated
- 27 May 2022
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Distribution
- Product was distributed to customers in AK and PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0788-2022
- 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 by: Lupin Pharma, Baltimore, MD 21202.
Terminated Class II Drugs
- Recall started
- 30 December 2021
- Terminated
- 28 March 2022
- Reason
- CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Distribution
- Product was distributed to one direct account in PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0366-2022
- Metformin 750 mg Extended Release NDC # 70518-2920-00
Terminated Class II Drugs
- Recall started
- 29 December 2021
- Terminated
- 14 April 2022
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Product was distributed to two direct accounts in MI and PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0360-2022
- 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: Ascend Labs, LLC, Montvale, NJ 07645
Terminated Class II Drugs
- Recall started
- 17 August 2021
- Terminated
- 9 March 2022
- Reason
- A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
- Distribution
- Product was distributed to two medical facilities in VA and FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0754-2021
- Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
Terminated Class II Drugs
- Recall started
- 11 October 2020
- Terminated
- 24 February 2021
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
- Distribution
- Product was distributed to one customer in PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0050-2021
- Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Terminated Class II Drugs
- Recall started
- 29 June 2020
- Terminated
- 14 September 2020
- Reason
- FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
- Distribution
- Product was distributed to MN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1387-2020
- Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.
Terminated Class I Drugs
- Recall started
- 27 December 2019
- Terminated
- 18 August 2020
- 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.
- Distribution
- Product distributed in OK and LA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0867-2020
- 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
Terminated Class II Drugs
- Recall started
- 11 December 2019
- Terminated
- 23 July 2020
- Reason
- CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
- Distribution
- Product was distributed to two facilities in CA and NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0798-2020
- Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Terminated Class II Drugs
- Recall started
- 5 August 2019
- Terminated
- 2 June 2023
- 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.
- Distribution
- PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1030-2020
- Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards).
Terminated Class II Drugs
- Recall started
- 22 April 2019
- Terminated
- 19 May 2020
- 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.
- Distribution
- Product was distributed to Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1270-2019
- Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
Terminated Class II Drugs
- Recall started
- 14 March 2019
- Terminated
- 11 April 2019
- Reason
- CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
- Distribution
- Product was distributed to one sole customer, Miami, FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1081-2019
- Losartan 50mg Tablet, 30 count each blister card.
Terminated Class III Drugs
- Recall started
- 7 November 2018
- Terminated
- 1 April 2019
- Reason
- Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
- Distribution
- Product was distributed to two medical facilities in Pennsylvania.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0284-2019
- Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01Repackaged NDC 70518
Terminated Class III Drugs
- Recall started
- 26 October 2018
- Terminated
- 5 February 2019
- Reason
- Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
- Distribution
- 1 vial was distributed to a medical facility in Mayville, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0245-2019
- Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
Terminated Class II Drugs
- Recall started
- 24 August 2018
- Terminated
- 29 October 2018
- Reason
- CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
- Distribution
- Product was distributed to a medical facility in South Carolina
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0093-2019
- Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
Terminated Class II Drugs
- Recall started
- 20 August 2018
- Terminated
- 10 October 2018
- Reason
- CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
- Distribution
- South Carolina
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1146-2018
- Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
Terminated Class II Drugs
- Recall started
- 10 August 2018
- Terminated
- 12 October 2018
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Distribution
- Product was distributed to three customers in FL and VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1101-2018, D-1102-2018, D-1100-2018
- Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
- Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
- Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
Terminated Class II Drugs
- Recall started
- 17 July 2018
- Terminated
- 17 October 2018
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Distribution
- Product was distributed to 3 medical facilities in Florida.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1021-2018, D-1020-2018
- Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
- Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.