Hazard

Manufacturing Deviation recalls

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

What the numbers show

Total: 294
Critical: 0
Severe: 6
Most recent: 2026-07-08

Of the 294 manufacturing deviation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (2%) are Severe.

Which agencies issued them

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.

76–100 of 294

ModerateFDA (Drugs)·D-0759-2023·2023-05-31
Glimepiride 4 Milligram Tablets Nationwide Recalled for Manufacturing Practice Deviations
Amerisource Health Services LLC is recalling 129,849 bottles of Glimepiride Tablets, USP 4 mg nationwide due to manufacturing practice deviations identified during an FDA inspection. No illnesses have been reported.
Product
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0565-2023·2023-05-10
Advil Dual Action Pain Reliever Recalled for Storage Temperature Deviation
Family Dollar Stores is recalling Advil Dual Action pain reliever tablets (36-caplet bottles, SKU 0902867) nationwide because the product was stored outside labeled temperature requirements.
Product
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0557-2023·2023-05-10
Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations
PD-Rx Pharmaceuticals has recalled 352 bottles of Montelukast Sodium USP 10 mg tablets distributed nationwide due to manufacturing process deviations. This was a voluntary recall by the firm.
Product
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0550-2023·2023-05-03
Prescription drug recall for manufacturing quality control deviations
Northwind Pharmaceuticals is recalling 33 bottles of Doxazosin 4mg tablets due to manufacturing quality control deviations. No illnesses or injuries have been reported.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
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
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
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-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-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-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-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-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-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-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-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-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
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-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-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-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-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-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