Hazard

Cgmp Deviation recalls

547 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 cgmp 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.

226–250 of 547

HighFDA (Drugs)·D-0460-2023·2023-03-22
Alprazolam Tablets Recalled for Potential Cross-Contamination from Manufacturing Deviations
Breckenridge Pharmaceutical is recalling Alprazolam 1 mg tablets distributed nationwide due to manufacturing practice deviations that pose a potential cross-contamination risk.
Product
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Bre
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0462-2023·2023-03-22
Clobazam tablets recalled for potential manufacturing cross-contamination risk
Breckenridge Pharmaceuticals is recalling certain lots of Clobazam 10 mg tablets due to a potential cross-contamination risk stemming from manufacturing process deviations.
Product
Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0444-2023·2023-03-15
FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations
Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.
Product
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0457-2023·2023-03-15
Drug Recall: Purely Soothing MSM Nasal Spray due to manufacturing deviations
Pharmedica USA is recalling Purely Soothing MSM Nasal Spray (15%, Lot #1808051) due to manufacturing practice violations. The recall affects 995 bottles distributed nationwide and internationally.
Product
Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0450-2023·2023-03-15
FDA Recalls Nose Better Gel Due to Manufacturing Process Deviations
Ecometics, Inc. is recalling Nose Better Gel nationwide due to manufacturing process deviations (CGMP violations). The firm-initiated voluntary recall affects 37,968 units with lot number 1E253A.
Product
Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0446-2023·2023-03-15
Drug Recall: Alcolado Relampago Topical for Manufacturing Practice Deviations
Ecometics recalls Alcolado Relampago topical product nationwide due to Current Good Manufacturing Practice deviations. About 18,000 bottles in 7 oz and 16 oz sizes were distributed in the U.S.
Product
Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0449-2023·2023-03-15
Drug manufacturer recalls Soltice Quick-RUB nationwide due to manufacturing deviations
Ecometics, Inc. recalled Soltice Quick-RUB nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This was a voluntary recall initiated by the manufacturer in February 2023.
Product
Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0443-2023·2023-03-15
FDA Class II: Phenylephrine Injection Recalled for Manufacturing Deviations
Denver Solutions is recalling 325,300 units of Phenylephrine HCl injection due to Current Good Manufacturing Practice deviations. The product was distributed nationwide, including to government facilities.
Product
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0442-2023·2023-03-15
Phenylephrine HCl syringe recalled for manufacturing practice deviations
Phenylephrine HCl syringe recalled for manufacturing practice deviations. 13,445 units distributed nationwide were recalled by Denver Solutions, LLC.
Product
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0366-2023·2023-03-08
Accord Healthcare Recalls Aripiprazole Tablets Due to Manufacturing Deviations
Accord Healthcare is recalling approximately 1.1 million bottles of Aripiprazole 5mg tablets due to Good Manufacturing Practice deviations identified during an FDA inspection. No illnesses or injuries have been reported.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0402-2023·2023-03-08
Phenylephrine Hydrochloride Injection Recalled for Manufacturing Practice Deviations
Accord Healthcare is recalling 5,090 vials of Phenylephrine Hydrochloride Injection due to manufacturing deviations found during an FDA inspection. Affected batches include R2101570, R2101574, and R2101576, distributed in the United States, Puerto Rico, and Canada.
Product
Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0425-2023·2023-03-08
Ropinirole tablets recalled due to FDA manufacturing compliance deviations
Accord Healthcare recalls 139,332 bottles of ropinirole 0.25 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing compliance deviations identified during FDA inspection.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0417-2023·2023-03-08
Tadalafil Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare recalls Tadalafil 20 mg tablets due to CGMP deviations identified during FDA inspection. Approximately 613,553 bottles distributed in the US, Puerto Rico, and Canada are affected.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0411-2023·2023-03-08
Simvastatin 40 mg tablets recalled for manufacturing practice deviations
Accord Healthcare is recalling 1,190,484 bottles of Simvastatin 40 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations identified during an FDA inspection.
Product
SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0406-2023·2023-03-08
FDA Recalls Rosuvastatin Tablets Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Rosuvastatin 20 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations. The deviations could affect product quality and safety.
Product
ROSUVASTATIN — ROSUVASTATIN (ROSUVASTATIN)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0424-2023·2023-03-08
Pravastatin Sodium 80 mg tablets recalled for manufacturing deviations
Accord Healthcare is recalling Pravastatin Sodium 80 mg tablets due to manufacturing process deviations discovered during an FDA inspection. The recall affects approximately 1,970 bottles distributed in the United States, Puerto Rico, and Canada.
Product
PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0379-2023·2023-03-08
FDA recalls Buspirone Hydrochloride tablets for manufacturing practice deviations
Accord Healthcare is recalling approximately 25,812 bottles of Buspirone Hydrochloride 30mg tablets due to manufacturing practice deviations discovered during an FDA inspection.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0374-2023·2023-03-08
Atorvastatin Calcium 80 mg tablets recalled for manufacturing quality deviations
Accord Healthcare recalls Atorvastatin Calcium 80 mg tablets due to manufacturing process deviations identified during FDA inspection. 72,376 bottles were distributed in the US, Puerto Rico, and Canada.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0388-2023·2023-03-08
Doxazosin tablets recalled due to manufacturing quality control deviations
Accord Healthcare is recalling 75,190 bottles of Doxazosin 4 mg tablets due to manufacturing quality control deviations discovered during an FDA inspection. No illnesses have been reported.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0429-2023·2023-03-08
FDA Recalls Ropinirole 3mg Tablets due to CGMP Deviations
Accord Healthcare's Ropinirole 3mg tablets are being recalled due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 14,928 bottles distributed in the United States, Puerto Rico, and Canada.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0390-2023·2023-03-08
Finasteride tablets recalled for manufacturing practice deviations
Accord Healthcare recalls 325,356 bottles of Finasteride 1 mg tablets due to manufacturing practice deviations identified during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.
Product
FINASTERIDE — FINASTERIDE (FINASTERIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0421-2023·2023-03-08
Pravastatin Sodium Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Pravastatin Sodium 10 mg tablets for CGMP deviations found during FDA inspection. About 9,600 bottles were distributed across the United States, Puerto Rico, and Canada. No illnesses reported.
Product
PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0407-2023·2023-03-08
Rosuvastatin tablets recalled for manufacturing quality control deviations
Accord Healthcare is recalling rosuvastatin 40 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found during an FDA inspection. No illnesses have been reported.
Product
ROSUVASTATIN — ROSUVASTATIN (ROSUVASTATIN)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0382-2023·2023-03-08
Daptomycin Injectable Recalled Due to Manufacturing Deviations
Accord Healthcare is recalling Daptomycin for Injection due to manufacturing practice deviations discovered during FDA inspection. No illnesses or injuries have been reported.
Product
DAPTOMYCIN — DAPTOMYCIN (DAPTOMYCIN)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0420-2023·2023-03-08
Pirfenidone Tablets Recalled Due to Manufacturing Compliance Deviations
Accord Healthcare is recalling Pirfenidone 801 mg tablets due to Current Good Manufacturing Practice deviations identified during an FDA inspection. Affected batches P2202519 and P2202513 were distributed in the United States, Puerto Rico, and Canada.
Product
PIRFENIDONE — PIRFENIDONE (PIRFENIDONE)
Category
Drug
Distribution
0 states