Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Philips X-ray imaging systems delivered to Puerto Rico are missing warning labels and Source-to-Skin Distance Spacers. These missing safety components could affect user safety during imaging procedures.
Philips is recalling 13 DigitalDiagnost 4 Chest/Emergency radiographic imaging units due to a potential for ceiling-mounted units to fail and fall, posing injury risk.
B. Braun is recalling SA3000 intravenous adapters due to a manufacturing defect that may cause leakage. This could delay therapy, increase bloodstream infection risk, and expose patients and workers to hazardous medication.
B. Braun Medical is recalling 12,800 units of TERUMO IV injection sets (Lot 0061753485) due to a manufacturing defect that may cause leakage, delaying therapy and increasing risk of bloodstream infection.
Maquet Medical Systems USA is recalling 1,022 Cardiohelp-i blood oxygenation systems due to an insufficient weld on a critical component that may break under manual force.
AbbVie is recalling 864 cartons of Synthroid (Levothyroxine Sodium) 125mcg tablets due to incorrect barcode labeling. About 1 in 40 blister packs has a barcode showing 200mcg instead of 125mcg, risking dosage confusion.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The product label indicates a 54-month shelf life, but the actual shelf life is 36 months.
V-Force Homeopathic bottles contain pig-derived adrenal gland instead of the labeled cow-derived ingredient. About 1,333 bottles with lot Z65842 distributed to Florida and potentially other states.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The label states a 54-month shelf life when the actual shelf life is 36 months.
Family Dollar recalls 329,044 units of GoodSense denture cleanser tablets that were stored outside their labeled temperature requirements. Products were sold between June and October 2023 at Family Dollar stores across 24 states.
OXAYDO oxycodone 7.5 mg tablets distributed nationwide are being recalled because they contain lower potency than labeled. The affected lot is 22W02 with expiration 01/31/2025.
Buprenorphine HCl injection is being recalled nationwide due to white crystalline agglomeration found in stored product samples during routine inspection.
The Sausage Maker, Inc. is recalling Instacure #1 curing salt due to potential metal contamination. Consumers who purchased this product online should discontinue use immediately.
Stryker recalls disposable Spetzler-Malis Bipolar forceps due to expiration date labeling error. Labels show 54-month shelf life but actual shelf life is 36 months.
Zydus Pharmaceuticals is recalling Oxybutynin Extended-Release Tablets (15 mg) after dissolution testing showed out-of-specification results at the 6-month mark. No illnesses have been reported.
Pulmonx endobronchial valve devices may have been labeled with a shortened expiration date. The devices are usable until December 8, 2024.
Glenmark Pharmaceuticals is recalling 16,944 bottles of Ranolazine 500mg tablets nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting drug efficacy.
Taro Pharmaceuticals recalls 11,196 bottles of Hydrocortisone and Acetic Acid Otic Solution nationwide due to failed quality specifications including out-of-spec impurities and lower-than-established assay levels discovered during stability testing.
Family Dollar is recalling 329,044 units of Fixodent denture cream products due to improper storage outside labeled temperature requirements. No illnesses or injuries have been reported.
Family Dollar's MEDIC's CHOICE contact lens solution was distributed between June and October 2023 due to storage outside labeled temperature requirements. Approximately 329,044 units were affected across 22 states.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an error in the product label's expiration date. The label indicates a 54-month shelf life when the actual shelf life is 36 months.
Stryker recalls disposable Spetzler-Malis bipolar forceps due to incorrect shelf life labeling. The label states 54 months but the actual shelf life is 36 months.
Stryker Corporation is recalling Spetzler-Malis Bipolar forceps due to incorrect shelf-life labeling. The devices are labeled with a 54-month shelf life but actually expire after 36 months.
Zydus Pharmaceuticals is recalling specific lots of oxybutynin chloride extended-release 10 mg tablets nationwide due to out-of-specification dissolution test results at the 6-month stability timepoint. The affected tablets may not release medication properly.
Family Dollar recalled 329,044 at-home marijuana test strips (SKU 900752) due to improper storage outside labeled temperature requirements. Products were distributed across 22 states between June and October 2023.