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 I · High risk

Phytonadione Injectable Emulsion

Defective Container: Recall is due to breaking and shattering of ampules upon opening

Terminated Packaging defect Dr. Reddy's Laboratories, Inc. NDC 43598-405-11 D-1094-2020
Class II · Moderate risk

Caduet (amlodipine besylate/atorvastatin calcium)

Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

Terminated Packaging defect Pfizer Inc. NDC 0069-2160-30 D-0842-2020
Class II · Moderate risk

Caduet (amlodipine besylate/atorvastatin calcium)

Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

Terminated Packaging defect Pfizer Inc. NDC 0069-2180-30 D-0841-2020
Class II · Moderate risk

Fentanyl Citrate Inj.

Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.

Terminated Packaging defect Pfizer Inc. NDC 00409-9094-12 D-0835-2020
Class II · Moderate risk

Netspot

Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

Terminated Packaging defect Advanced Accelerator Applications USA, Inc. NDC 69488-001-40 D-0799-2020
Class III · Low risk

VCF Vaginal Contraceptive Foam

Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable

Terminated Packaging defect Apothecus Pharmaceutical Corp. NDC 52925-312-14 D-0623-2020
Class III · Low risk

Clobetasol Propionate Foam

Defective delivery system; product is not foaming or is coming out as liquid.

Terminated Packaging defect Glenmark Pharmaceuticals Inc., USA NDC 68462-625-27 D-0619-2020
Class III · Low risk

Clobetasol Propionate Foam

Defective delivery system; product is not foaming or is coming out as liquid.

Terminated Packaging defect Glenmark Pharmaceuticals Inc., USA NDC 68462-608-27 D-0618-2020
Class II · Moderate risk

Estradiol Vaginal Inserts USP

Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.

Terminated Packaging defect Glenmark Pharmaceuticals Inc., USA NDC 68462-711-71 D-0156-2020
Class I · High risk

Natpara (parathyroid hormone)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Terminated Packaging defect Shire Human Genetic Therapies, Inc. D-0038-2020
Class I · High risk

Natpara (parathyroid hormone)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Terminated Packaging defect Shire Human Genetic Therapies, Inc. NDC 68875-0204-02 D-0037-2020
Class I · High risk

Natpara (parathyroid hormone)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Terminated Packaging defect Shire Human Genetic Therapies, Inc. NDC 68875-0203-02 D-0036-2020
Class I · High risk

Natpara (parathyroid hormone)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Terminated Packaging defect Shire Human Genetic Therapies, Inc. NDC 68875-0202-02 D-0035-2020
Class II · Moderate risk

Estradiol Vaginal Inserts USP 10 mcg

Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

Terminated Packaging defect Glenmark Pharmaceuticals Inc., USA NDC 68462-711-71 D-1340-2019
Class III · Low risk

Diclofenac Sodium Topical Solution

Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

Terminated Packaging defect Ingenus Pharmaceuticals Llc NDC 50742-308-05 D-1058-2019