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.
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Labeling: Incorrect or Missing Package Insert
Labeling: Incorrect or Missing Package Insert
Labeling: Incorrect or Missing Package Insert
Labeling: Incorrect or Missing Package Insert
Labeling: Incorrect or Missing Package Insert
Product mixup: one foreign tablet found in product.
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Labeling; Incorrect NDC number on outer carton of product.
Labeling: Label Mix-up
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Labeling: Not elsewhere classified
Labeling: Incorrect or Missing Lot and/or Exp Date
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
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