fda regulated Recalls
1,320 recalls tagged with “fda regulated”.
Mindray Sevoflurane V90 Vaporizer Recalled for Leakage Risk in A9 System (148 Units)
Mindray DS USA recalled 148 Sevoflurane V90 electronic vaporizers used with the A9 Anesthesia System. The devices have a potential for anesthesia leakage. Healthcare facilities should stop using the device immediately and follow manufacturer instructions.
123Herbals SILINTAN 25-Pill Meloxicam Recall in 2026
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Mindray DS USA Recalls 54 Isoflurane V90 Vaporizers for A9 Anesthesia System Over Leakage Risk (2025
Straumann USA Recalls 61 Emdogain Demonstration Dental Devices (2025)
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
M.C.I. Foods Recalls 1,040 Cases of Ready-to-Eat Egg & Cheese Breakfast Burritos and Wraps (2025)
Cooked egg ingredient for Ready-to-Eat products tested positive for Listeria Monocytogenes
DERMASENSOR DermaSensor 10101 Diagnostic Device Recalled for 9 of 343 Units (2025)
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Major Pharmaceuticals Gabapentin 100 mg 10-Capsule Recall Nationwide 2025
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Lannett NIACIN ER 1,000 mg Recall Affects 46,848 Bottles Nationwide (2025)
470 Doctor D. Schwab Controlling Cream Tubes Recalled for CGMP Deviations
Elixir by Coco March Tinted Mineral Sunscreen SPF 50 Recalled for CGMP Deviations
CLEARSTEM You Are Sunshine SPF 50 Sunscreen Recalled for CGMP Deviations (Visage)
Dr. Bump Gel Menthol 5% Recall for 4,890 Bottles Over CGMP Deviations
Gabriel Mineral Sunscreen SPF 50 Recalled for CGMP Deviations in 1617 Tubes
Weh-Weh Pain Reliever Gel Recalled for CGMP Deviations, 810 Tubes Affected (2025)
CA Botana Sunscreen Flawless Skin Fluid Tint SPF 50 Recall 2025
CA Botana International recalls Sunscreen Flawless Skin Fluid Tint SPF 50 after CGMP deviations. The recall covers 1,401 tubes distributed to California, Colorado, Florida, Puerto Rico and Washington. Stop using the product and contact CA Botana for guidance.
CA Botana Doctor D. Schwab Shimmery Sun Lotion Sunscreen Recall for CGMP Deviations (2025)
Gabapentin 100 mg Capsules Recalled by Major Pharmaceuticals in 2025, 100-Count Pack
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50 Recalled for CGMP Deviations (Class II)
STAQ Pharma FentaNYL Citrate PF IV Injection Recall 2025 Over Labeling Errors
STAQ Pharma recalled FentaNYL Citrate PF IV injection nationwide after labeling left incorrect or missing lot and expiration dates. Healthcare providers must stop using the product immediately. STAQ Pharma will provide recall instructions by letter.