Class III · Low risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect Product Formulation
Other reasons
Recalls whose stated reason does not fall into the categories above. See the recall's own reason text for the specifics.
342 FDA drug recalls with this cause, newest first.
A small share of recalls carry a stated reason that does not fit any category above - a firm's own complaint investigation, an adverse-event report, or wording too specific to classify automatically. The original FDA wording is shown on each recall so you can read exactly what happened.
- Total recalls
- 342
- Class I (high risk)
- 3
- Currently ongoing
- 23
- Most recent
- Jul 16, 2026
Most-cited firms for this cause
- Main Street Family Pharmacy, LLC298
- Xiamen Kang Zhongyuan Biotechnology Co., Ltd.15
- Washington Homeopathic Products, Inc.3
- SigmaPharm Laboratories LLC2
- Pharmedium Services, LLC2
- Dr. Reddy's Laboratories, Inc.2
- Winder Laboratories, LLC1
- Westlab Pharmacy, Inc. dba Westlab Pharmacy1
Class II · Moderate risk
QC Quality Choice
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
QC Quality Choice
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
QC Quality Choice
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
QC Quality Choice
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
QC Quality Choice
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
QC Quality Choice
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
QC Quality Choice
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
MGC Health
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
MGC Health
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
MGC Health
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
Discount Drug Mart Food Market
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
Discount Drug Mart Food Market
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
caring mill
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
exchange select
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
exchange select
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Class II · Moderate risk
BD ChloraPrep" Triple Swabsticks
Lack of Assurance of Sterlity
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class III · Low risk
SinuFrin Decongestant
Sub-potent Drug
Class II · Moderate risk
Phenazopyridine HCl Tablets USP
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class III · Low risk
Glimepiride Tablets
Misprint on tablet
Class III · Low risk
Glimepiride Tablets
Misprint on tablet
Class III · Low risk
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class II · Moderate risk
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial
Sub-potent Drug
Class II · Moderate risk
FentaNYL Citrate 2.5 mg/50 mL
Underfilled units.
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