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

Ventolin HFA

Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.

Terminated Packaging defect GlaxoSmithKline, LLC NDC 0173-0682-20 D-0519-2016
Class III · Low risk

Hydrocortisone and Acetic Acid Otic Solution

Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.

Terminated Packaging defect Akorn, Inc. NDC 50383-901-10 D-0295-2016
Class II · Moderate risk

Combivent Respimat

Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.

Terminated Packaging defect Boehringer Ingelheim Roxane Inc NDC 0597-0024-02 D-1279-2015
Class III · Low risk

Carb-O-Philic 40 Cream

CGMP Deviation: Poor container closure of the bulk storage container

Terminated Packaging defect Geritrex Corp NDC 54162-640-03 D-1238-2015
Class II · Moderate risk

Haloperidol Oral Solution

Defective Container: Confirmed customer complaints of leaking bottles.

Terminated Packaging defect Safecor Health, LLC NDC 54838-0501-40 D-0661-2016
Class II · Moderate risk

Gentamicin Injection

Defective Container: Vials may be missing stoppers.

Terminated Packaging defect Fresenius Kabi USA, LLC NDC 63323-010-20 D-0290-2015
Class III · Low risk

Mucinex DM

Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch

Terminated Packaging defect Reckitt Benckiser LLC NDC 63824-056-72 D-0964-2015
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-1608-2014
Class II · Moderate risk

Tyvaso (treprostinil)

Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.

Terminated Packaging defect United Therapeutics Corp. D-1423-2014
Class III · Low risk

Spiriva HandiHaler

Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.

Terminated Packaging defect Boehringer Ingelheim Roxane Inc NDC 0597-0075-75 D-1230-2014
Class II · Moderate risk

Lupron Depot

Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.

Terminated Packaging defect AbbVie Inc NDC 0074-3642-03 D-1291-2014
Class II · Moderate risk

Lupron Depot

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

Terminated Packaging defect AbbVie Inc NDC 0074-3663-03 D-1290-2014
Class II · Moderate risk

Lupron Depot-Ped

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

Terminated Packaging defect AbbVie Inc NDC 0074-3779-03 D-1289-2014