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.

151–175 of 314

ModerateFDA (Drugs)·D-0485-2023·2023-04-05
Simvastatin 20mg Tablets Recalled for Manufacturing Practice Deviations
Direct Rx recalled Simvastatin 20mg tablets nationwide due to manufacturing practice deviations. The voluntary recall affects bottles distributed across the United States.
Product
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0482-2023·2023-04-05
Glimepiride tablet recall due to manufacturing practice deviations
Direct Rx is recalling Glimepiride 4 mg tablets nationwide due to manufacturing process deviations. The recall is voluntary and affects specific lots of 30-count and 90-count bottles.
Product
Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0477-2023·2023-04-05
Finasteride Tablets Recalled Nationwide for Manufacturing Practice Deviations
Direct Rx is recalling 19 bottles of Finasteride 5 mg Tablets nationwide due to cGMP deviations. The firm initiated this recall voluntarily.
Product
Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0478-2023·2023-04-05
Prescription Drug Ropinirole 0.25 mg Tablets Recalled for Manufacturing Deviations
Direct Rx is recalling Ropinirole, USP, 0.25 mg tablets (NDC 72189-0364-30, Lot 21JU2210) nationwide due to Good Manufacturing Practice (cGMP) deviations. The firm voluntarily initiated this recall on March 13, 2023.
Product
Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0484-2023·2023-04-05
Drug Manufacturer Recalls Simvastatin Tablets for Manufacturing Deviations
Direct Rx recalled Simvastatin 10 mg tablets nationwide due to manufacturing process deviations discovered during production. No illnesses or injuries have been reported.
Product
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0476-2023·2023-04-05
Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations
Direct Rx is recalling Montelukast Sodium 10 mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects approximately 508 bottles distributed across the United States.
Product
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0486-2023·2023-04-05
Simvastatin Tablets Recalled Nationwide Over Manufacturing Practice Deviations
Direct Rx is recalling 269 bottles of Simvastatin 40 mg nationwide due to Good Manufacturing Practice deviations. No adverse events have been reported. Consult your healthcare provider before changing your medication.
Product
Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0459-2023·2023-03-22
Alprazolam Tablets Recalled Due to Potential Cross-Contamination Risk
Breckenridge Pharmaceutical is recalling multiple lots of Alprazolam 0.5mg tablets nationwide due to manufacturing process deviations that created a potential cross-contamination risk.
Product
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: B
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0445-2023·2023-03-15
FDA Recalls Phenylephrine IV Solution for Manufacturing Practice Deviations
Denver Solutions recalls 8,136 units of Phenylephrine HCl IV solution nationwide due to manufacturing practice deviations. The FDA classified this Class II recall as affecting prescription injectable solutions distributed to hospitals and government facilities.
Product
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0438-2023·2023-03-15
NatraBio Cold and Sinus Nasal Spray Recalled for Manufacturing Deviation
Nutraceutical Corporation is recalling NatraBio Cold & Sinus Nasal Spray (0.8 FL Oz) lot 222016 due to manufacturing deviations and product discoloration. The product was distributed nationwide.
Product
NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0451-2023·2023-03-15
Sodium fluoride oral rinse recalled for manufacturing deviations
Activator Concentrate, a sodium fluoride oral rinse manufactured by Ecometics, Inc., was voluntarily recalled due to manufacturing practice deviations. The recall affected 34,320 bottles distributed nationwide.
Product
Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0447-2023·2023-03-15
Medicated Balm Recalled for Manufacturing Process Deviations
Ecometics, Inc. is voluntarily recalling Vencedor medicated balm (capsaicin 0.028%) nationwide due to manufacturing process deviations. The recall affects Lot #2E021A with expiration date January 2025.
Product
Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0365-2023·2023-03-08
Aripiprazole tablets recalled due to manufacturing process deviations
Accord Healthcare is recalling 747,464 bottles of Aripiprazole 2mg tablets due to manufacturing process deviations discovered during an FDA inspection. The affected medication was distributed in the United States, Puerto Rico, and Canada.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0372-2023·2023-03-08
Atorvastatin Calcium tablets recalled due to manufacturing practice deviations
Accord Healthcare is recalling Atorvastatin Calcium 20 mg tablets due to manufacturing practice deviations found during an FDA inspection. The affected products were distributed in the United States, Puerto Rico, and Canada.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0369-2023·2023-03-08
Aripiprazole 20 mg Tablets Recalled for Manufacturing Quality Deviations
Accord Healthcare is recalling 170,448 bottles of Aripiprazole 20 mg tablets distributed in the United States, Puerto Rico, and Canada due to manufacturing quality control (CGMP) deviations identified during FDA inspection.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0405-2023·2023-03-08
Accord Healthcare recalls Rosuvastatin tablets for manufacturing deviations
Accord Healthcare is recalling Rosuvastatin 10 mg tablets due to manufacturing deviations identified during FDA inspection. No illnesses or injuries have been reported.
Product
ROSUVASTATIN — ROSUVASTATIN (ROSUVASTATIN)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0403-2023·2023-03-08
Phenylephrine Hydrochloride Injection recalled due to manufacturing practice deviations
Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing practice deviations discovered during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.
Product
Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0416-2023·2023-03-08
Tadalafil tablets recalled for manufacturing quality control deviations
Accord Healthcare is recalling Tadalafil 10 mg tablets in the United States, Puerto Rico, and Canada due to manufacturing quality control deviations discovered during an FDA inspection.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0393-2023·2023-03-08
Accord Healthcare recalls Glimepiride tablets due to manufacturing practice deviations
Accord Healthcare is recalling Glimepiride 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations discovered during an FDA inspection. The recall affects 469,944 bottles.
Product
GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0364-2023·2023-03-08
Sterile Water for Injection Recalled Due to Manufacturing Quality Deviations
Nephron Sc Inc recalls 325,080 vials of Sterile Water for Injection due to manufacturing quality deviations that could result in product carryover. Affected lots expire December 31, 2023.
Product
STERILE WATER — STERILE WATER (STERILE WATER)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0384-2023·2023-03-08
Dofetilide antiarrhythmic prescription drug recalled for manufacturing deviations
Accord Healthcare is recalling 113,571 bottles of dofetilide capsules distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection. No illnesses have been reported.
Product
DOFETILIDE — DOFETILIDE (DOFETILIDE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0415-2023·2023-03-08
FDA Recalls Tadalafil Tablets Due to Manufacturing Practice Deviations
Accord Healthcare's Tadalafil 5 mg tablets are being recalled due to deviations from current good manufacturing practices identified during an FDA inspection. Approximately 1,113,264 bottles were distributed across the United States, Puerto Rico, and Canada.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0377-2023·2023-03-08
FDA Recalls Accord Healthcare Buspirone 15 mg Tablets for Manufacturing Deviations
Accord Healthcare is recalling 10,992 bottles of Buspirone Hydrochloride 15 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found during an FDA inspection.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0396-2023·2023-03-08
Glycopyrrolate Injection, USP recalled for manufacturing practice deviations
Accord Healthcare recalls Glycopyrrolate Injection USP following FDA inspection identifying manufacturing deviations. Approximately 23,814 vials distributed to the US, Puerto Rico, and Canada are affected.
Product
GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0398-2023·2023-03-08
Glycopyrrolate injection recalled due to manufacturing practice deviations
Accord Healthcare recalls Glycopyrrolate injection due to manufacturing practice deviations found during FDA inspection. The recall affects 3,164 vials distributed in the US, Puerto Rico, and Canada.
Product
GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
Category
Drug
Distribution
0 states