Class II · Moderate risk
Exenatide Injection
Defective Delivery System: Possibility of no medication in the prefilled pen.
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.
- Total recalls
- 318
- Class I (high risk)
- 23
- Currently ongoing
- 80
- Most recent
- Aug 28, 2026
Most-cited firms for this cause
- Noven Pharmaceuticals, Inc.32
- Noven Pharmaceuticals Inc16
- Glenmark Pharmaceuticals Inc., USA12
- Teva Pharmaceuticals USA11
- Safecor Health, LLC11
- FDC Limited11
- Aurobindo Pharma USA Inc.9
- Novocol Pharmaceutical of Canada, Inc.7
Class II · Moderate risk
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Class II · Moderate risk
safco SensiCaine-Ultra
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
PureLife
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Dental City TOPICAL ANESTHETIC GEL
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Burkhart topical anesthetic gel
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
DHP Topical Anesthetic Gel
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Quala Dental Products
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Pearson Quality Topical Anesthetic Gel
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Estradiol Gel
Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk
Desmopressin Nasal Spray
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Class II · Moderate risk
Midodrine Hydrochloride Tablets
Defective container; inadequately sealed blister packaging.
Class II · Moderate risk
Cetrorelix Acetate for Injection
Defective Delivery System: Missing or duplicated needles within the injection kit
Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk
Ondansetron ODT Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class III · Low risk
Carton label: Testosterone Gel 1%
Defective Container - A defect in the side-seal which allows leakage of product.
Class II · Moderate risk
Sertraline Hydrochloride Tablets USP
Defective container - seal not adhering to bottles
Class II · Moderate risk
OraVerse
Defective container: cracked/broken cartridges
Class II · Moderate risk
Cook-Walte
Defective container: cracked/broken cartridges
Class II · Moderate risk
Benco dental Graham CHEMICAL CO.
Defective container: cracked/broken cartridges
Class II · Moderate risk
darby dental supply
Defective container: cracked/broken cartridges
Class II · Moderate risk
3% Polocaine DENTAL
Defective container: cracked/broken cartridges
Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
Class II · Moderate risk
2% Xylocaine DENTAL with Epinephrine 1:100
Defective container: cracked/broken cartridges
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