Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Packaging & closure defects

Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination.

318 FDA drug recalls with this cause, newest first.

These recalls involve the container rather than the contents - failed child-resistant closures, leaking bags or vials, cracked cartridges, blister packs with holes, or a delivery device (pump, applicator, syringe) that does not work as designed. A seal problem can let contamination in after the product leaves the factory, and a failed child-resistant cap puts children at risk of accidental exposure.

Class II · Moderate risk

Alka-Seltzer Original

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

Terminated Packaging defect Bayer HealthCare Pharmaceuticals, Inc. D-1044-2017
Class II · Moderate risk

Ventolin HFA

Defective Delivery System: Elevated number of units with out of specification results for leak rate.

Ongoing Packaging defect GlaxoSmithKline, LLC NDC 0173-0682-20 D-0626-2017
Class I · High risk

EpiPen Jr. 2-Pak

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

Ongoing Packaging defect Meridian Medical Technologies a Pfizer Company NDC 49502-500-02 D-0691-2017
Class I · High risk

EpiPen 2-Pak

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

Ongoing Packaging defect Meridian Medical Technologies a Pfizer Company NDC 49502-500-02 D-0690-2017
Class II · Moderate risk

Docetaxel Injection USP

Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.

Terminated Packaging defect Dr. Reddy's Laboratories, Inc. NDC 43598-611-11 D-0213-2018
Class III · Low risk

Azelastine Hydrochloride Nasal Solution

Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..

Terminated Packaging defect Roxane Laboratories, Inc. NDC 0054-0293-99 D-0448-2017
Class I · High risk

GlucaGen HypoKit

Defective delivery system: detached needles on the syringe in the kit.

Terminated Packaging defect Novo Nordisk Inc NDC 0169-7065-15 D-0217-2017
Class II · Moderate risk

Transderm Scop

Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.

Terminated Packaging defect Sandoz Inc D-0133-2017
Class I · High risk

Cetylev (acetylcysteine)

Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.

Terminated Packaging defect Arbor Pharmaceuticals Inc. NDC 24338-700-10 D-0105-2017
Class II · Moderate risk

Sclerosol Intrapleural Aerosol

Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.

Terminated Packaging defect Lymol Medical NDC 63256-100-30 D-0858-2016
Class II · Moderate risk

Norditropin FlexPro Somatropin

Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step

Terminated Packaging defect Novo Nordisk Inc NDC 0169-7703-21 D-0956-2016
Class II · Moderate risk

Oxycodone Hydrochloride Oral Solution

Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.

Terminated Packaging defect VistaPharm, Inc. NDC 66689-401-01 D-0838-2016
Class II · Moderate risk

Tudorza Pressair

Defective Delivery System: Some units have actuation counters set to a number other than 60.

Terminated Packaging defect AstraZeneca Pharmaceuticals LP D-0781-2016
Class II · Moderate risk

Guaifenesin DM Cherry liquid

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

Terminated Packaging defect Perrigo Company PLC NDC 49348-828-34 D-0587-2016
Class II · Moderate risk

Guaifenesin Grape liquid 100 mg/5 mL

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

Terminated Packaging defect Perrigo Company PLC NDC 37808-288-26 D-0586-2016
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5555-3 D-1440-2016
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1439-2016
Class II · Moderate risk

Daytrana (methylphenidate transdermal system)

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-5553-3 D-1438-2016