Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose.
1,411 FDA drug recalls with this cause, newest first.
This is exactly what it sounds like: the wrong label on the right product, the wrong strength printed on the bottle, a missing or illegible lot number and expiry date, or two products mixed up during packaging. It is dangerous precisely because the pill or liquid itself may be fine, yet the patient has no way of knowing what they are actually taking. A high share of the Class I recalls in this group are mix-ups where a stronger product ended up in a weaker product's packaging.
Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
Labeling: Label Mix-up
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Labeling: Incorrect or Missing Lot and/or Exp Date
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Labeling: Missing Label
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Labelling: Illegible label
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Tablets/Capsules Imprinted with Wrong ID
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
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