Recalls, Market Withdrawals, & Safety Alerts
The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.
The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.
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| Date | Brand Name(s) | Product Description | Product Type | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
|---|---|---|---|---|---|---|---|
| Par Pharmaceutical | Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) | Drugs | Product is an unapproved drug. | Endo, Inc. | … all lots within expiry of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) 30mg/30mL (1mg/mL) 30 mL … in appearance to the FDA-approved drug product Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial, also … This recall does not include the approved Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial. Risk … | ||
| Spectrum | Epinephrine bulk API | Drugs | Product discoloration | Spectrum Laboratory Products Inc. | Terminated | … Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical … have found the product to be discolored. Risk Statement: Epinephrine is a critical medication used during … with a less-effective product, essentially underdosing epinephrine, could result in death. Spectrum Laboratory … |