Class II · Moderate risk
NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution
Failed Reconstitution time
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.
Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
Class II · Moderate risk
Carvedilol 25 mg
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
Class II · Moderate risk
Miss Slim
Marketed without ANDA/NDA approval
Class III · Low risk
Asenapine Sublingual Tablets
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III · Low risk
Asenapine Sublingual Tablets
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III · Low risk
Lcl-2-0191
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Class III · Low risk
Sp-4
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Class III · Low risk
Macula Pellets Homeopathic Medicine
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Class I · High risk
Hydromorphone HCl in 0.9% sodium chloride
Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
Class II · Moderate risk
Fentanyl Citrate 2 mcg per mL
Sub-potent
Class II · Moderate risk
Fentanyl Citrate 2 mcg per mL
Sub-potent
Class III · Low risk
Norepinephrine 8 mg
Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class II · Moderate risk
Megestrol Acetate Oral Suspension
Supterpotent Drug
Class II · Moderate risk
Alprostadil 500 mcg/mL Injectable
Incorrect Product Formulation
Class II · Moderate risk
Omega-3-Acid Ethyl Esters Capsules USP
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Class II · Moderate risk
Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes
First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).
Class II · Moderate risk
VIVITROL (naltrexone for extended-release injectable suspension)
Customer complaints for failure to deliver the dose.
Class II · Moderate risk
Wydase 1ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Trypan Blue 0.15% 1ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Tri-Mix SS Pap 30mg
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Tri-Mix SS Pap 30mg
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone Acetonide 40mg/ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone 40mg PF 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Triamcinolone Diacetate 40mg 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
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