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 |
|---|---|---|---|---|---|---|---|
| Healthy Living | Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets | Drugs | Device & Drug Safety - Mislabeling | Aurobindo Pharma USA, Inc. | … lot (refer table below) of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg … Name, strength, and pack Lot number Expiry 58602-882-21 Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg tablets – … label) to end users. Healthy Living Migraine Relief, Acetaminophen, Aspirin (NSAID) & Caffeine tablets are … | ||
| Hikma | Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL | Drugs | Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL). | Hikma Pharmaceuticals PLC | … extending its voluntary recall of one lot (listed below) of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) to the … (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL). If the provider does not identify the drug inside the acetaminophen overwrap as dexmedetomidine and administers … | ||
| Infla-650 | Infla-650 Herbal Dietary Supplement Capsules | Dietary Supplements, Drugs | Tainted with the drug ingredients: acetaminophen, diclofenac and phenylbutazone | Guru Inc. | … level. Infla-650 capsules has been found to be tainted with acetaminophen, diclofenac and phenylbutazone , which are not listed on the label. Products containing acetaminophen, diclofenac and phenylbutazone cannot be … threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in … | ||
| Supercore Products Group | Dietary Supplements for Male Sexual Enhancement. | Dietary Supplements | Tainted with Sildenafil and Acetaminophen. | Supercore Products Group | … has found these products to be tainted with Sildenafil and acetaminophen. Sildenafil is an ingredient known as a … who use nitrates for cardiac conditions are most at risk. Acetaminophen is a medicine used to reduced pain and fever … threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in … |