FDA Enforcement · Jul 15, 2026
Drug recall: Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7…
Subpotent drug — Gasco Industrial Corp. · Class II · Ongoing · N/A
Recalls & Safety · page 10
Recalls and safety alerts from the FDA, newest first.
FDA Enforcement · Jul 15, 2026
Drug recall: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL
Subpotent drug — Gasco Industrial Corp. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG
cGMP deviations — Shimoga Chemicals · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only
Lack of Sterility Assurance — Reliance Life Sciences Private Limited · Class II · Ongoing · 5,020 vials
FDA Enforcement · Jul 15, 2026
Drug recall: Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL).
Subpotent drug — Gasco Industrial Corp. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter)
Subpotent drug — Gasco Industrial Corp. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use
Lack of Sterility Assurance — Reliance Life Sciences Private Limited · Class II · Ongoing · 11,400 vials
FDA Enforcement · Jul 15, 2026
Drug recall: Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only
Lack of Sterility Assurance — Reliance Life Sciences Private Limited · Class II · Ongoing · 12,000 vials
FDA Enforcement · Jul 15, 2026
Drug recall: Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and…
Lack of Sterility Assurance — Reliance Life Sciences Private Limited · Class II · Ongoing · 8,001 vials
FDA Enforcement · Jul 15, 2026
Drug recall: Medline Remedy Specialized Silicone Cream (Hydraguard-D )
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. — BioMed Laboratories, LLC. · Class II · Ongoing · 509,652 tubes
FDA Enforcement · Jul 15, 2026
Drug recall: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL
Subpotent drug — Gasco Industrial Corp. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Drug recall: Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL
Failed Impurities/Degradation Specifications — QuVa Pharma, Inc. · Class II · Ongoing · N/A
FDA Enforcement · Jul 15, 2026
Device recall: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Surgical dressing manufactured out of specification (greater thickness). — ConvaTec, Inc · Class II · Ongoing · 4230 units
FDA Enforcement · Jul 15, 2026
Device recall: GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC.…
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results. — WALLAC OY · Class II · Ongoing · 3,274 units
FDA Enforcement · Jul 15, 2026
Device recall: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
A product error defect may cause incorrect bracket placement. — Klowen Braces · Class II · Ongoing · 3 units
FDA Enforcement · Jul 15, 2026
Device recall: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or … — Medtronic MiniMed, Inc. · Class II · Ongoing · 778
FDA Enforcement · Jul 15, 2026
Device recall: Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope…
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers. — Olympus Corporation of the Americas · Class II · Ongoing · 988700 units
FDA Enforcement · Jul 15, 2026
Device recall: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number:…
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. — CMR SURGICAL LIMITED · Class II · Ongoing · 2
FDA Enforcement · Jul 15, 2026
Device recall: Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. — Medline Industries, LP · Class II · Ongoing · 1400 kits
FDA Enforcement · Jul 15, 2026
Device recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results. — Siemens Healthcare Diagnostics, Inc. · Class II · Ongoing · 24,077 units
FDA Enforcement · Jul 15, 2026
Device recall: Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading…
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. — Elekta, Inc. · Class II · Ongoing · 1
FDA Enforcement · Jul 15, 2026
Device recall: 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD…
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. — Fresenius Medical Care Holdings, Inc. · Class II · Ongoing · 113,544 units (4,731 cases)
FDA Enforcement · Jul 15, 2026
Device recall: Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description:…
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. — Elekta, Inc. · Class II · Ongoing · 586
FDA Enforcement · Jul 15, 2026
Device recall: Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for…
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. — Elekta, Inc. · Class II · Ongoing · 1317