Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Reliable Compounding Pharmacy is recalling all estriol products compounded between March 2015 and March 2016 due to a lack of processing controls.
Lyne Laboratories is recalling specific lots of Cyproheptadine Hydrochloride Syrup because the product was found to be subpotent. The recall affects 12,215 bottles distributed in New Jersey.
Reliable Drug is recalling all Jack Newman Cream Products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Drug is recalling all fluconazole products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Compounding Pharmacy is recalling all budesonide products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Drug/Reliable Compounding Pharmacy is recalling all mirtazapine products compounded between March 24, 2015, and March 24, 2016, due to a lack of processing controls.
Reliable Compounding Pharmacy is recalling all quinine products compounded between March 2015 and March 2016 due to a lack of processing controls.
Synthes (USA) Products LLC is recalling 6,255 Ti Button Plate units because their MR safety information does not meet current ASTM standards.
Reliable Drug is recalling all thymol products compounded between March 2015 and March 2016 due to a lack of processing controls.
Medtronic Navigation is recalling 63 O-arm 02 surgical x-ray imaging systems nationwide due to gaps in electronic product labeling and Instructions for Use compliance.
Reliable Drug is recalling compounded monobenzone products due to a lack of processing controls. The recall covers lots compounded between March 2015 and March 2016.
Reliable Compounding Pharmacy is recalling all capsicum products due to a lack of processing controls. The products were distributed in California, Hawaii, and New Mexico.
Reliable Drug is recalling all compounded sucralfate products due to a lack of processing controls. The recall covers products distributed in California, Hawaii, and New Mexico.
Reliable Compounding Pharmacy is recalling all acyclovir and lidocaine products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Rexall-A Compounding Pharmacy is recalling all compounded thyroid products due to a lack of processing controls.
Reliable Drug is recalling all fluoxymesterone products compounded between March 2015 and March 2016 due to a lack of processing controls.
ZYTO Technologies is voluntarily recalling ZYTO Tower and software programs because their claims exceeded the scope of their FDA 510(k) clearance.
General Motors is recalling 2016-2017 Buick Envision vehicles because the Tire and Loading Information label may display incorrect maximum weight information, which could lead to vehicle overloading.
CMP Industries is recalling 77 units of IMPAK Liquid Acrylic Resin due to the possible presence of foreign material (rust). The affected product is distributed in six US states and Canada.
Smith & Nephew is recalling 10 units of Legion HK Femoral Assemblies because the internal cement surface is below specification.
Actavis Pharma Inc. is voluntarily recalling Ciprofloxacin Ophthalmic Solution due to out-of-specification results for an unknown impurity near expiration.
CMP Industries is recalling specific lots of IMPAK Liquid Acrylic Resin due to the possible presence of foreign material (rust). The affected products are used for dental applications.
Siemens is recalling 74 Syngo.plaza PACS systems due to a software error that may create duplicate image references in the database.
Dako North America Inc. is recalling 31 kits of the HER2 CISH pharmDx Kit because the HER2 probe concentration was too low.
Philips is recalling 19 Ingenuity Core 128 CT scanners because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.