Hazard

Manufacturing Deviation recalls

314 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing deviation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

126–150 of 314

ModerateFDA (Drugs)·D-0540-2023·2023-05-03
Pantoprazole Sodium Injection 40 mg Recalled Due to Manufacturing Procedure Deviation
Methapharm Inc is recalling Pantoprazole Sodium 40 mg injection vials due to a manufacturing procedure deviation. Affected products were inadvertently placed into distribution without proper compliance with approved procedures.
Product
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0549-2023·2023-05-03
Drug Recall: Buspirone Tablets Over Manufacturing Process Deviations
Northwind Pharmaceuticals is recalling Buspirone Hydrochloride 7.5 mg tablets due to manufacturing process deviations. The FDA Class II recall affects bottles distributed nationwide.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0553-2023·2023-05-03
Tadalafil Tablets 20 mg recalled due to manufacturing deviations
Northwind Pharmaceuticals voluntarily recalls Tadalafil 20 mg tablets nationwide due to manufacturing practice deviations. No illnesses have been reported.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0518-2023·2023-04-12
Montelukast Sodium Tablets Recalled for Manufacturing Deviations
Preferred Pharmaceuticals is recalling Montelukast Sodium Tablets, USP, 10 mg due to current Good Manufacturing Practice deviations discovered during an FDA inspection. The product was distributed nationwide.
Product
Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0520-2023·2023-04-12
Rosuvastatin Tablets Recalled Due to Manufacturing Deviations
Preferred Pharmaceuticals is recalling 264 bottles of Rosuvastatin Tablets 5mg nationwide due to manufacturing deviations discovered during FDA inspection. No illnesses have been reported.
Product
Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0513-2023·2023-04-12
Clopidogrel Tablets 75 mg Recalled for Manufacturing Quality Deviations
Preferred Pharmaceuticals is recalling Clopidogrel Tablets 75 mg nationwide due to manufacturing quality deviations found at manufacturer Accord Healthcare. The recall affects specific lot codes expiring October 2023.
Product
Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0496-2023·2023-04-12
Simvastatin 10 mg Tablets Recalled for Manufacturing Practice Deviations
RemedyRepack Inc. voluntarily recalled Simvastatin 10 mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lots distributed to consignees throughout the United States.
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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0494-2023·2023-04-12
Ropinirole 0.5 mg tablets recalled for manufacturing quality deviations
RemedyRepack Inc. is recalling 17 bottles of Ropinirole 0.5 mg tablets due to manufacturing process deviations. The product was distributed nationwide within the United States.
Product
Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0492-2023·2023-04-12
Doxazosin 2 mg tablets recalled for manufacturing practice deviations
RemedyRepack Inc. is voluntarily recalling Doxazosin 2 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 30-count and 90-count bottles.
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.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0498-2023·2023-04-12
Drug recall: Atorvastatin 20 mg tablets due to manufacturing process deviations
RemedyRepack Inc. is recalling 3,426 bottles of Atorvastatin 20 mg tablets nationwide due to Good Manufacturing Practice (cGMP) deviations. The recall was initiated voluntarily by the manufacturer.
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.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0522-2023·2023-04-12
Simvastatin Tablets Recalled Due to Manufacturing Compliance Deviations
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 10 mg due to manufacturing compliance deviations identified at Accord Healthcare. No illnesses or injuries have been reported.
Product
Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0526-2023·2023-04-12
Prescription Tadalafil tablets recalled for manufacturing process deviations
Preferred Pharmaceuticals is recalling 32 bottles of Tadalafil 20 mg tablets due to manufacturing process deviations identified during FDA inspection. The recalled lots expire January 31, 2024.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0527-2023·2023-04-12
Glimepiride Tablets Recall Due to Manufacturing Quality Deviations
Preferred Pharmaceuticals is recalling Glimepiride Tablets 4 mg due to Current Good Manufacturing Practice (cGMP) deviations identified at the manufacturer, Accord Healthcare. The recall affects 15 bottles distributed nationwide.
Product
Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0515-2023·2023-04-12
Doxazosin Tablets Recalled Due to Manufacturing Process Deviations
Preferred Pharmaceuticals is recalling Doxazosin Tablets, USP, 4 mg (lot L1522V, expiration 4/30/2025) due to current Good Manufacturing Practice deviations discovered during FDA inspection of the manufacturer, Accord Healthcare. The product was distributed nationwide.
Product
Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0500-2023·2023-04-12
Rosuvastatin 5mg Tablets Recalled Due to Manufacturing Deviations
RemedyRepack Inc. voluntarily recalled 132 bottles of Rosuvastatin 5mg tablets nationwide due to current Good Manufacturing Practice deviations. No illnesses or injuries have been reported.
Product
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0524-2023·2023-04-12
Simvastatin Tablets Recalled Due to Manufacturing Process Deviations
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 20 mg, in three package sizes due to manufacturing process deviations at Accord Healthcare. The affected tablets were distributed nationwide.
Product
Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0503-2023·2023-04-12
Drug Recall: Simvastatin tablets due to manufacturing deviations
RemedyRepack Inc. is recalling Simvastatin 40 mg tablets nationwide due to manufacturing deviations. The voluntary recall was initiated in March 2023.
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0499-2023·2023-04-12
Ropinirole 2mg Tablets Recalled for Manufacturing Practice Deviations
RemedyRepack Inc. is recalling Ropinirole 2mg tablets due to manufacturing practice deviations. No illnesses have been reported.
Product
Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0495-2023·2023-04-12
Drug Recall: Rosuvastatin 5mg Tablets for Manufacturing Deviations
RemedyRepack Inc. is recalling 399 bottles of Rosuvastatin 5mg tablets nationwide due to manufacturing deviations. No illnesses have been reported.
Product
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0502-2023·2023-04-12
Rosuvastatin 40mg tablets recalled nationwide for manufacturing process deviations
RemedyRepack is voluntarily recalling Rosuvastatin 40mg tablets due to manufacturing practice deviations. The recall affects specific lot numbers expiring 07/31/2025 distributed nationwide.
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.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0497-2023·2023-04-12
Drug Recall: Tadalafil 5 mg Tablets Due to Manufacturing Deviations
RemedyRepack Inc. recalled Tadalafil 5 mg tablets due to cGMP manufacturing process deviations. The recall affected 16 bottles distributed nationwide; no illnesses have been reported.
Product
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2023·2023-04-12
Glimepiride 2 mg Tablets Recalled for Manufacturing Quality Deviations
RemedyRepack Inc. is recalling Glimepiride 2 mg tablets distributed nationwide due to manufacturing quality deviations (cGMP violations). The recall affects 220 bottles across multiple lot numbers.
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
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0517-2023·2023-04-12
Glimepiride Tablets Recalled Due to Manufacturing Process Deviations
Preferred Pharmaceuticals recalls Glimepiride Tablets, 2 mg, 90-count bottles due to manufacturing process deviations discovered during FDA inspection. No illnesses have been reported.
Product
Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0491-2023·2023-04-12
Drug Recall: Atorvastatin 10 mg tablets due to manufacturing process violations
RemedyRepack Inc. is recalling specific lots of Atorvastatin 10 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated March 20, 2023.
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.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0533-2023·2023-04-05
Dabigatran Etexilate Drug Recalled Due to N-nitroso Impurity
Ascend Laboratories is recalling 13,560 bottles of Dabigatran Etexilate 75 mg capsules nationwide because testing detected N-nitroso-dabigatran impurity levels above acceptable limits. The issue stems from a manufacturing quality control deviation.
Product
DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
Category
Drug
Distribution
Distributed nationwide