25 FDA recalls mention Oxycodone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Oxycodone.
Reason Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Reason Sub-potent Drug: Lower potency than labeled.
Reason Impurity failure at 0-time of the repackaged lot.
Reason Out-of-specification impurity test result observed at 18-month long term stability time point.
Reason Labeling: Missing Label
Reason Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Reason Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices…
Reason Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Reason Failed Impurities/Degradation Specification; 9 month stability
Reason Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing…
Reason Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for…
Reason Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Reason Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Reason Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen…
Reason Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result…
Reason Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10…
Reason Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
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