Drug recalls
500 recallsMed Pride, Bacitracin Zinc Ointment, 500 units
Dabur India Limited
CGMP Deviations;
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg
Ascend Laboratories, LLC
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9…
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS
Haleon US Holdings LLC
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machin…
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse
BEEKEEPER'S NATURALS USA INC.
Microbial Contamination of Non-Sterile Products
Budesonide Inhalation Suspension, 1mg/2mL
SUN PHARMACEUTICAL INDUSTRIES INC
Presence of Foreign Substance:This recall has been initiated in response to a product quality com…
Zep, Alcohol Sanitizer Spray, Ethanol 70%
Zep Inc
Microbial contamination of sterile products
Duloxetine Delayed-Release Capsules, USP, 60mg
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only
Fresenius Kabi USA, LLC
Failed Impurities/Degradations Specifications
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL)
SUN PHARMACEUTICAL INDUSTRIES INC
Presence of Particulate matter: Particulate matter identified as glass.
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only
Amneal Pharmaceuticals, LLC
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetac…
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG
Golden State Medical Supply Inc.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was o…
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only
Spectra Medical Devices, Llc
Lack of Assurance of Sterility
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL)
Eugia US LLC
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
TopCare health, ULTRA STRENGTH, Antacid Tablets
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 10…
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only
SUN PHARMACEUTICAL INDUSTRIES INC
Labeling: Not Elsewhere Classified.
Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only
Ascend Laboratories, LLC
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications