Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1651–1675 of 3531

ModerateFDA (Devices)·Z-1215-2023·2023-03-15
epoc Host 2 Diagnostic Analyzers Recalled for Oxygen Measurement Inaccuracy
Siemens Healthcare Diagnostics is recalling 4,369 epoc Host 2 blood gas analyzers due to elevated oxygen measurements in quality control testing when adjusted for barometric pressure. No illnesses reported.
Product
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
Category
Medical Device
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-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-0454-2023·2023-03-15
OTC Hemorrhoidal Ointment Recalled for Missing Lot and Expiration Date
Akron Pharma is recalling Dibucaine 1% Hemorrhoidal Ointment due to incorrect or missing lot and expiration date information on the label. This labeling error affects 4,416 tubes distributed nationwide.
Product
DIBUCAINE — DIBUCAINE (DIBUCAINE)
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
ModerateFDA (Drugs)·D-0401-2023·2023-03-08
Accord Healthcare recalls phenylephrine injection vials due to manufacturing deviations
Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing deviations found during FDA inspection. No illnesses or injuries have been reported.
Product
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton ND
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0413-2023·2023-03-08
Accord Recalls Succinylcholine Chloride Injection Due to Manufacturing Deviations
Accord Healthcare is recalling Succinylcholine Chloride Injection due to manufacturing practice deviations discovered during FDA inspection. The recall affects 48,089 cartons distributed to the U.S., Puerto Rico, and Canada.
Product
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-
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-0349-2023·2023-03-08
Microcrystalline Cellulose Ingredient Recalled Over Failed Impurity Specifications
DuPont Nutrition USA, Inc. is recalling certain batches of Avicel PH-101 microcrystalline cellulose because it failed quality testing for impurities and degradation. The ingredient showed out-of-specification conductivity levels.
Product
Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Cope
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0354-2023·2023-03-08
Gabapentin 600 mg Tablets Recalled Due to Dosage Strength Mix-Up
Sciegen Pharmaceuticals is recalling 4,392 bottles of Gabapentin 600 mg tablets after a pharmacist discovered some 800 mg tablets mixed into bottles.
Product
GABAPENTIN — GABAPENTIN (GABAPENTIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0426-2023·2023-03-08
Ropinirole Tablets Recalled for Manufacturing Practice Deviations
Accord Healthcare recalls 181,848 bottles of Ropinirole 0.5 mg tablets distributed in the U.S., Canada, and Puerto Rico due to manufacturing practice deviations identified during an FDA inspection.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0376-2023·2023-03-08
Accord Healthcare Recalls Buspirone Hydrochloride Due to Manufacturing Deviations
Accord Healthcare is recalling 24,408 bottles of Buspirone Hydrochloride tablets due to Current Good Manufacturing Practice deviations discovered during an FDA inspection.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-0388-2023·2023-03-08
Hot chocolate and cappuccino products recalled for undeclared peanut allergen
Corim Industries is recalling Agglomerated Peanut Butter Hot Chocolate and Peanut Butter Cappuccino products in multiple formats due to undeclared peanut allergen on the label.
Product
Smart Sips, 24 ct single serve coffee pods (12.7 oz carton)
Category
Food
Distribution
4 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
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
ModerateFDA (Drugs)·D-0375-2023·2023-03-08
Buspirone Hydrochloride tablets recalled for manufacturing practice deviations
Accord Healthcare is recalling Buspirone Hydrochloride 7.5 mg tablets (23,784 bottles) distributed in the US, Puerto Rico, and Canada due to manufacturing practice deviations identified during FDA inspection.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-0395-2023·2023-03-08
Drizzilicious Mini Rice Cake Bites Recalled for Undeclared Peanut Residue
Snack Innovations Inc. is recalling Drizzilicious Mini Rice Cake bites for possible undeclared peanut residue. Consumers with peanut allergies should not consume the product.
Product
Drizzilicious Mini Rice Cake bites Net Wt. 4oz and/or .74oz Bags Salted Caramel UPC:857900005167 and 857900005181 Packaged in a plastic bags Product also packed in the Drizzilicious mini rice cakes 32-ct Variety box
Category
Food
Distribution
10 states
ModerateFDA (Drugs)·D-0418-2023·2023-03-08
Vigabatrin Oral Solution Recalled for Manufacturing Quality Deviations
Accord Healthcare is recalling 821 cartons of Vigabatrin for Oral Solution due to manufacturing quality deviations found during an FDA inspection. The product was distributed in the United States, Puerto Rico, and Canada.
Product
Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC 16729-52
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0430-2023·2023-03-08
Ropinirole Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling 8,184 bottles of Ropinirole 4 mg tablets due to manufacturing practice deviations found during an FDA inspection. The recalled batches were distributed in the United States, Puerto Rico, and Canada.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0394-2023·2023-03-08
Glimepiride 2 mg tablets recalled for manufacturing practice deviations
Accord Healthcare recalls Glimepiride 2 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. Approximately 992,622 bottles across multiple batches are affected.
Product
GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0368-2023·2023-03-08
Aripiprazole 15 mg Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Aripiprazole 15 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during an FDA inspection.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
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-0386-2023·2023-03-08
Prescription Doxazosin Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling 44,068 bottles of Doxazosin 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations found during an FDA inspection.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0431-2023·2023-03-08
Ropinirole Tablets Recalled Due to Manufacturing Quality Violations
Accord Healthcare is recalling Ropinirole 5mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recall affects 5,112 bottles distributed in the United States, Puerto Rico, and Canada.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0385-2023·2023-03-08
FDA Recalls Dofetilide Antiarrhythmic Drug for Manufacturing Deviations
Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing compliance deviations identified during FDA inspection. The recall affects approximately 113,003 bottles distributed in the U.S., Puerto Rico, and Canada.
Product
DOFETILIDE — DOFETILIDE (DOFETILIDE)
Category
Drug
Distribution
0 states