The Recall Desk

Manufacturer

RemedyRepack Inc.

61 recalls in our database name RemedyRepack Inc. as the manufacturing or recalling firm.

What the numbers show

Total
61
Critical
1
Severe
13
Most recent
2025-05-14

Of the 61 recalls from RemedyRepack Inc. we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 13 (21%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 61

  • HighFDA (Drugs)·D-0077-2023·2022-12-14

    Desmopressin Acetate Tablets Recalled by Manufacturer for Subpotency

    RemedyRepack Inc. is recalling Desmopressin Acetate Tablets due to subpotency. The affected tablets may not provide the intended therapeutic effect.

    Product
    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 #: 70518-3493-00.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1538-2022·2022-09-21

    Lisinopril 10 mg Tablets Recalled for Metal Fragment Contamination

    RemedyRepack Inc. is recalling Lisinopril 10 mg prescription tablets due to a metal fragment embedded in one tablet. Affected lots were distributed to pharmacies in Pennsylvania and Alaska.

    Product
    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
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0887-2022·2022-06-01

    Losartan HCTZ tablets recalled for manufacturing impurity levels above acceptable limits

    RemedyRepack Inc. is recalling Losartan HCTZ 100/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recall affects bottles distributed to Florida, South Carolina, and Virginia.

    Product
    Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0885-2022·2022-06-01

    Losartan HCTZ Medication Recalled for Elevated AZIDO Impurity

    RemedyRepack Inc. is recalling Losartan HCTZ 50/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled product was distributed to Florida.

    Product
    Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0886-2022·2022-06-01

    Losartan HCTZ drug recall due to azido impurity levels above limits

    RemedyRepack Inc. is recalling Losartan HCTZ 100/25 mg tablets distributed in Florida, South Carolina, and Virginia due to azido impurity levels exceeding acceptable manufacturing limits.

    Product
    Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0788-2022·2022-05-04

    Losartan Potassium 50 mg tablets recalled due to azido impurity

    RemedyRepack Inc. is recalling Losartan Potassium 50 mg tablets due to CGMP deviations with azido impurity levels above acceptable limits. The affected lots were distributed to customers in Alaska and Pennsylvania.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0366-2022·2022-01-19

    Metformin 750 mg Extended Release Recalled for NDMA Contamination

    RemedyRepack Inc. is recalling Metformin 750 mg Extended Release (NDC # 70518-2920-00) due to detection of N-Nitrosodimethylamine (NDMA) levels exceeding the acceptable daily intake limit. The product was distributed to one direct account in Pennsylvania.

    Product
    Metformin 750 mg Extended Release NDC # 70518-2920-00
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0360-2022·2022-01-12

    Cefixime 400 mg Capsules Recalled for Failed Impurities and Degradation Specifications

    RemedyRepack Inc. is recalling Cefixime 400 mg capsules distributed in Michigan and Pennsylvania due to failed impurities and degradation specifications. The affected products may not meet established quality and safety standards.

    Product
    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
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0754-2021·2021-09-01

    Carvedilol 25 mg Tablets Recalled Due to Foreign Medication Contamination

    RemedyRepack Inc. is recalling Carvedilol 25 mg tablets after discovering that a 500-count source bottle contained two Paroxetine tablets (40 mg), which were then repackaged into 180-count bottles distributed to medical facilities in Virginia and Florida.

    Product
    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
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0050-2021·2020-11-04

    RemedyRepack Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    RemedyRepack Inc. is recalling Metformin Hydrochloride Extended Release 750 mg tablets because of detected NDMA impurity levels above acceptable intake limits.

    Product
    Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1387-2020·2020-07-22

    RemedyRepack Recalls Carbamazepine 200 mg Tablets Due to Dissolution Failure

    RemedyRepack Inc. is recalling Carbamazepine 200 mg tablets because routine stability testing revealed low dissolution results.

    Product
    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.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1030-2020·2020-03-25

    Lisinopril/HCTZ Tablets Recalled Due to Foreign Tablet Presence

    RemedyRepack Inc. is recalling Lisinopril/HCTZ tablets because a foreign Fenofibrate tablet was found in the product bottle.

    Product
    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).
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0867-2020·2020-02-19

    RemedyRepack Recalls Ketorolac Tromethamine Injections Due to Particulate Matter

    RemedyRepack Inc. is recalling 75 vials of Ketorolac Tromethamine 30 mg/1mL injections distributed in Oklahoma and Louisiana due to the presence of small black particles.

    Product
    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
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0798-2020·2020-01-29

    RemedyRepack Recalls Ranitidine Tablets Due to Potential NDMA Contamination

    RemedyRepack Inc. is recalling specific lots of Ranitidine 150 mg tablets because the supplier reported potential Nitrosodimethylamine (NDMA) levels above established limits.

    Product
    Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1270-2019·2019-05-08

    Losartan Potassium/HCTZ Tablets Recalled for Nitrosamine Impurity

    RemedyRepack is recalling Losartan Potassium/HCTZ tablets because FDA testing found a nitrosamine impurity above acceptable levels.

    Product
    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.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1081-2019·2019-04-17

    RemedyRepack Recalls Losartan 50mg Tablets Due to Impurity

    RemedyRepack Inc. is recalling Losartan 50mg tablets because trace amounts of an unexpected impurity, NMBA, were detected in the active ingredient.

    Product
    Losartan 50mg Tablet, 30 count each blister card.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0284-2019·2018-12-05

    RemedyRepack Recalls Nitrofurantoin Capsules Due to Cross-Contamination

    RemedyRepack Inc. is recalling specific lots of Nitrofurantoin Monohydrate/Macrocrystals capsules due to potential cross-contamination with unrelated ingredients.

    Product
    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 70518-1087-00, 14 capsules in HDPE 60 cc bottles in cardboard tra
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0245-2019·2018-11-21

    RemedyRepack Recalls Metoprolol Tartrate Injection Due to pH Failures

    RemedyRepack Inc. is recalling specific lots of Metoprolol Tartrate Injection because stability testing showed high pH levels that failed specifications.

    Product
    Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0093-2019·2018-10-31

    RemedyRepack Recalls Amlodipine/Valsartan HCTZ Tablets Due to NDMA Contamination

    RemedyRepack Inc. is recalling Amlodipine/Valsartan HCTZ tablets due to trace amounts of NDMA detected in the active ingredient.

    Product
    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
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1146-2018·2018-09-05

    RemedyRepack Recalls Amlodipine/Valsartan/HCTZ Tablets Due to NDMA Contamination

    RemedyRepack Inc. is recalling Amlodipine/Valsartan/HCTZ tablets in South Carolina due to trace amounts of NDMA, a possible impurity.

    Product
    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
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1102-2018·2018-08-22

    RemedyRepack Recalls Valsartan 320 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling specific lots of Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    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
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1101-2018·2018-08-22

    RemedyRepack Recalls Valsartan 160 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan 160 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    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
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1100-2018·2018-08-22

    RemedyRepack Recalls Valsartan 80 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the product.

    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, NDC 61786-0791-19
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1020-2018·2018-08-08

    RemedyRepack Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan/HCTZ 160 mg/12.5 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1021-2018·2018-08-08

    RemedyRepack Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling specific lots of Valsartan/HCTZ tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
    Category
    Drug
    Distribution
    1 state