Browse Drug Recalls
4 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 4 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 4 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 19, 2024 | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx onl... | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... | Class II | Hikma Injectables USA Inc |
| Dec 19, 2024 | ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, ... | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... | Class II | Hikma Injectables USA Inc |
| Apr 30, 2024 | Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged... | Labeling: Wrong Barcode | Class III | Hikma Injectables USA Inc |
| Apr 29, 2024 | Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL,... | Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. | Class I | Hikma Injectables USA Inc |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.