Drug Recalls
A drug recall is one of the most effective ways to protect consumers from a defective or potentially harmful medicine. A recall is a voluntary action taken by a company to remove a defective drug from the market or warn patients and consumers about a potential risk.
- Visit Drug recall information for consumers, health care professionals and industry for more information.
- Visit Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.
- Follow FDA Recall Information on X.
Company recall announcements are posted below:
| Date | Brand Name(s) | Product Description | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
|---|---|---|---|---|---|---|
| Fresenius Kabi | Famotidine Injection, USP 20 mg per 2 mL | Out-of-specification endotoxin results | Fresenius Kabi USA, LLC | |||
| ICU Medical | 20 mEq Potassium Chloride Injection | Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection | Otsuka ICU Medical LLC | |||
| Green Lumber | Dietary Supplement | Undeclared prescription drug-Tadalafil | Green Lumber Holding, LLC. | |||
| DermaRite | Hand Sanitizers, Cleansers, Skin Protectants, Deodorant | Device & Drug Safety - Potential Burkholderia cepacian contamination | DermaRite Industries | |||
| Unichem Pharmaceuticals | Cyclobenzaprine Hydrochloride Tablets USP 10 mg | Device & Drug Safety – Mislabel | Unichem Pharmaceuticals | |||
| B. Braun | Lactated Ringer’s Injection USP 1000 mL/0.9% Sodium Chloride Injection USP 1000 mL | Due to the presence of particulate matter. | B. Braun Medical, Inc. | |||
| DermaKleen, Dermasarra, Kleenfoam, and Perigiene | OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic cleansers | Contamination with Burkholderia cepacia | DermaRite Industries, LL | |||
| Nostrum Laboratories | Sucralfate Tablets USP 1 gram | Company closure and discontinuation of quality activities. | Nostrum Laboratories, Inc. | |||
| Sandoz | Cefazolin for Injection, USP, 1 gm vial | Potential Presence of Penicillin G Potassium Injection Vial | Sandoz Inc. | |||
| Zicam® and Orajel™ | Cold Remedy Nasal Swabs, Nasal AllClear Swabs, Baby Teething Swabs | Microbial contamination | Church & Dwight Co., Inc. |