RemedyRepack Inc.: 61 FDA recall reports
Every drug recall the FDA has published for RemedyRepack Inc.. The fault, and how the agency graded it.
61Reports
1Class I
5Ongoing
2025-05-14Most recent
1 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., India
D-0411-2025 · Class II · reported 2025-05-14 · Ongoing
- Why it was recalled
- CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
- Product
- Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
- Where it went
- Within U.S - PA, VA, FL.
- How much
- 23 bottles/30 count- 690 capsules
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., India
D-0378-2025 · Class II · reported 2025-04-30 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
- Where it went
- PA
- How much
- 1,858 30-count blister cards
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, M
D-0217-2025 · Class II · reported 2025-02-12 · Terminated
- Why it was recalled
- CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
- Product
- 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.
- Where it went
- FL
- How much
- 247 blister packs
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles
D-0165-2025 · Class II · reported 2025-01-01 · Ongoing
- Why it was recalled
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Product
- 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 by: RemedyRepack Inc., Indiana, PA
- Where it went
- Nationwide in the US
- How much
- a) 1,564 cards, b) 799 bottles
Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glen
D-0611-2024 · Class II · reported 2024-07-24 · Terminated
- Why it was recalled
- CGMP Deviations: Out of specification for dissolution
- Product
- 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
- Where it went
- USA Nationwide
- How much
- 142 blister cards, 30 per blister card
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA N
D-0549-2024 · Class II · reported 2024-06-19 · Terminated
- Why it was recalled
- Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Product
- 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
- Where it went
- Product was distributed to one medical facility.
- How much
- 8 bottles
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack
D-0489-2024 · Class II · reported 2024-05-15 · Terminated
- Why it was recalled
- 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
- Product
- 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, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762
- Where it went
- Nationwide in the USA
- How much
- 23,970 Tablets
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged
D-0577-2023 · Class II · reported 2023-05-24 · Ongoing
- Why it was recalled
- 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.
- Product
- 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;
- Where it went
- Product was distrituded to three direct account in PA.
- How much
- 12 5mL bottles
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC
D-0578-2023 · Class II · reported 2023-05-24 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 # 61748-0012-01
- Where it went
- Product was distrituded to three direct account in PA.
- How much
- 29 x 30-count card, 1 x 100 UD box
LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged
D-0576-2023 · Class II · reported 2023-05-24 · Terminated
- Why it was recalled
- 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.
- Product
- 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
- Where it went
- Product was distrituded to three direct account in PA.
- How much
- 9,038 vials
Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70
D-0496-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- 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
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- a) 1,262 bottles, b) 95 bottles
Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA
D-0499-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- 3 bottles
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70
D-0503-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- 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
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 7
D-0491-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- 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.
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- a) 3,497 bottles, b) 729 bottles
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-
D-0493-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- 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 15701
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- a) 147 bottles, b)70 bottles, c) 3 bottles
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70
D-0497-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- 16 bottles
Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70
D-0498-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- 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.
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- 3,426 bottles
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 7
D-0502-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- 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.
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- a) 76 bottles, b)151 bottles
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC
D-0495-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- 399 bottles
Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-
D-0492-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- 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: RemedyRepack Inc., Indiana, PA 15701.
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- a) 58 bottles, b) 6 bottles
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC
D-0500-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- 132 bottles
Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC
D-0490-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- 3 bottles
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-cou
D-0501-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- 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), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- a) 399 bottles, b)445 bottles
Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, P
D-0494-2023 · Class II · reported 2023-04-12 · Terminated
- Why it was recalled
- cGMP Deviations
- Product
- Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
- Where it went
- RemedyRepack distributed product to consignees nationwide within the United States
- How much
- 17 bottles
Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original ND
D-0098-2023 · Class II · reported 2023-01-18 · Terminated
- Why it was recalled
- Failed Impurities/Degradation specifications
- Product
- 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.
- Where it went
- Product was distributed to one account in PA.
- How much
- 132 Cards of 30 = 3960 Tablets
Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceutic
D-0077-2023 · Class II · reported 2022-12-14 · Terminated
- Why it was recalled
- Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
- 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.
- Where it went
- Product was distributed to two different customers in MI.
- How much
- 9 boxes
Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: Reme
D-1538-2022 · Class II · reported 2022-09-21 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
- 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
- Where it went
- Distributed to two direct accounts in PA and AK.
- How much
- 1,699 blister cards/30 tablets each
Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
D-0886-2022 · Class II · reported 2022-06-01 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Product
- Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
- Where it went
- Product was distributed to FL, SC and VA
- How much
- 26/90 count bottles = 2,340 tablets
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
D-0887-2022 · Class II · reported 2022-06-01 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Product
- Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
- Where it went
- Product was distributed to FL, SC and VA
- How much
- 30 bottles/90 count = 2,700 tablets
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
D-0885-2022 · Class II · reported 2022-06-01 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
- Where it went
- Recalled product was distributed to Florida.
- How much
- 22 bottles/90 count each
Showing the 30 most recent of 61. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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