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 |
|---|---|---|---|---|---|---|---|
| Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg | Drugs | Potential cross contamination with Ranitidine | Unique Pharmaceutical Laboratories | … Rising Pharma Holdings Inc. … Unique Pharmaceutical Laboratories … FOR IMMEDIATE RELEASE – July 18th, 2026 – … by email and is arranging for the return of all recalled products. Consumers with general or medical inquiries regarding this recall can contact Rising … | ||
| Nostrum Laboratories | Sucralfate Tablets USP 1 gram | Drugs | Company closure and discontinuation of quality activities. | Nostrum Laboratories, Inc. | … Nostrum Laboratories … Nostrum Laboratories, Inc. … NEW YORK, DC, … by Nostrum Labs after June 2023. No other Nostrum Labs products are affected by this recall. Nostrum Labs … at issue here to wholesalers, retailers, manufacturers, medical facilities, and repackagers. It cannot be guaranteed … | ||
| Rugby | OTC Ophthalmic Sterile Drops | Drugs | Insanitary manufacturing conditions | The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories | Terminated | … Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories … FOR IMMEDIATE RELEASE – October 31, 2023 – La … facility. Risk Statement: For those patients who use these products, there is a potential risk of eye infections that … products should talk to their health care provider or seek medical care immediately. Adverse reactions or quality … | |
| Major Pharmaceuticals | Dronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules 20mg | Drugs | Packaging may contain incorrect product due to labeling mix-up | The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories | Terminated | … Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories … FOR IMMEDIATE RELEASE – June 13, 2023 – La … of self-harm or harm to others which could result in medical or psychiatric hospitalization. Taking an unexpected … Hydrochloride Capsules, 20 mg, can be found below. Products were distributed Nationwide to Wholesalers starting … |