Class II · Moderate risk
Glycopyrrolate Tablets
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Particulate & foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables.
867 FDA drug recalls with this cause, newest first.
These recalls involve visible foreign material - glass, metal, fibers, rubber or other debris - most often found in injectable or liquid products, where nothing besides the intended ingredients should be present. It also includes foreign tablets or capsules found in a bottle of a different product. In an injectable a stray particle can go straight into the bloodstream, which is why a noticeable share of these recalls are Class I.
Class I · High risk
Sodium Acetate Injection
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Class II · Moderate risk
Chlorthalidone Tablets USP 25 mg
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Class I · High risk
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class II · Moderate risk
Metoprolol Tartrate Tablets
Complaint received of foreign matter (metal) embedded in tablet.
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter: Identified as Glass Particles
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class II · Moderate risk
Metoprolol Tartrate Tablets USP 100 mg
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Class I · High risk
AMINOSYN II 15% An Amino Acid Injection
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Class II · Moderate risk
Carvedilol Tablets
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Class II · Moderate risk
Clopidogrel Tablets
Presence of foreign matter
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of Foreign Substance- Potential of metal contamination.
Class I · High risk
Topotecan Injection 4 mg/4mL
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Class II · Moderate risk
DermOtic Oil
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class II · Moderate risk
Diflorasone Diacetate Ointment USP
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent and Presence of Particulates .
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Metformin HCl Extended-Release Tablets
Presence of foreign substance: identified as activated carbon.
Class II · Moderate risk
Sterile Water for Inj.
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class III · Low risk
Olmesartan Medoxomil Tablets
Presence of Foreign Tablet/Capsule
Class II · Moderate risk
0.9% SODIUM CHLORIDE Irrigation
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Class II · Moderate risk
Famotidine Tablets USP 40mg
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.