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 |
|---|---|---|---|---|---|---|---|
| Multiple brand names | All FDA-regulated products held at facility including drugs, medical devices, cosmetics, dietary supplements, human food, and pet food | Animal & Veterinary, Foodborne Illness, Cosmetics, Foodborne Illness, Dietary Supplements, Foodborne Illness, Drugs, Foodborne Illness, Food & Beverages, Foodborne Illness, Medical Devices, Foodborne Illness | Potential Salmonella contamination, presence of rodent and avian contamination and insanitary conditions during the storage process. | Gold Star Distribution, Inc. | … 12CT 686464554206 19PSC3 E (2/12PK) SPRITE TEA CANS 10PP99A ICU CYCLOPS MONSTER 12CT 686464544207 19PSC3L (2/12PK) … W BRUSH (WHITENING) 6.4oz/24ct 808829106879 16DGM GARLIC MINCED 0.75OZ/12CT 1007611438032 8;076114380321 35TCF1 ADULT … excreta, rodent urine, and bird droppings in areas where medical devices, drugs, human food, pet food, and cosmetic … | ||
| ICU Medical | 20 mEq Potassium Chloride Injection | Drugs | Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection | Otsuka ICU Medical LLC | … ICU Medical … Otsuka ICU Medical LLC … FOR IMMEDIATE RELEASE – October 31, 2025 … label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product as POTASSIUM CHLORIDE Inj. … | ||
| Olympus | Bronchofiberscopes and bronchovideoscopes | Medical Devices | Potential for endobronchial combustion | Olympus Corporation | … – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further … therapeutic instruments with Olympus bronchoscopes, which included one death. Since the Field Corrective Action in … prolonged procedure, extended hospitalization or ICU care, and death. Combustion can also result in damage to … | ||
| ICU Medical | POTASSIUM CHLORIDE Inj. 20 mEq and 10 mEq | Drugs | Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq. | ICU Medical | … ICU Medical … ICU Medical … FOR IMMEDIATE RELEASE – February 13, 2025 LAKE FOREST, Illinois – ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM … | ||
| Smith’s Medical | CADD Infusion System Infusion Sets for use with CADD pumps | Medical Devices | Potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms. | Smith’s Medical | … Smith’s Medical … Smith’s Medical … MINNEAPOLIS, Dec. 12, 2022 … Media Contact: Tom McCall 949-366-4368 tom.mccall@icumed.com SOURCE ICU Medical, Inc. … CADD Infusion System Infusion Sets for use with … |