Drug Recalls
RSS ↗1,842 drug recalls from federal enforcement feeds.
Showing 1,401–1,450 of 1,842
- Class I
Drug Recall · June 25, 2024
Amerisource Health Services LLC
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark PharmaceuticalFailed Dissolution Specifications
- Class III
Drug Recall · June 25, 2024
Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, UPC code: 8-40078-56731-5Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
- Class III
Drug Recall · June 25, 2024
Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
- Class III
Drug Recall · June 25, 2024
Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC Code: 8-40078-56612-7Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
- Class III
Drug Recall · June 25, 2024
Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC 73423-003-01; UPC Code: 8-40078-56493-2Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
- Class II
Drug Recall · June 24, 2024
Amerisource Health Services LLC
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
- Class III
Drug Recall · June 24, 2024
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
- Class II
Drug Recall · June 21, 2024
Zydus Pharmaceuticals (USA) Inc
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences LtFailed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
- Class I
Drug Recall · June 21, 2024
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
- Class II
Drug Recall · June 18, 2024
Fresenius Medical Care Holdings, Inc.
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-PyrogeniThis product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
- Class II
Drug Recall · June 18, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 1Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
- Class III
Drug Recall · June 18, 2024
Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals LimitSubpotent drug: out of specification results
- Class II
Drug Recall · June 17, 2024
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
- Class II
Drug Recall · June 17, 2024
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 ULack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
- Class II
Drug Recall · June 12, 2024
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
- Class II
Drug Recall · June 10, 2024
Brands International Corporation
Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON,Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
- Class II
Drug Recall · June 7, 2024
Dr. Reddy's Laboratories, Inc.
Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01.Presence of foreign substance.
- Class II
Drug Recall · June 5, 2024
STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
- Class I
Drug Recall · June 5, 2024
STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
- Class III
Drug Recall · June 4, 2024
Dr. Reddy's Laboratories, Inc.
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30Failed Impurities/Degradation Specifications: Related Substances
- Class III
Drug Recall · May 31, 2024
Washington Homeopathic Products, Inc.
Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic Products, Inc., Berkley Springs, WV 25411, UPC 7 40640 64300 6.Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
- Class II
Drug Recall · May 31, 2024
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GAProduct Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Class I
Drug Recall · May 30, 2024
Glenmark Pharmaceuticals Inc., USA
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-DFailed Dissolution Specifications
- Class II
Drug Recall · May 30, 2024
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited,Failed Content Uniformity Specifications
- Class I
Drug Recall · May 30, 2024
Glenmark Pharmaceuticals Inc., USA
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-DFailed Dissolution Specifications
- Class I
Drug Recall · May 28, 2024
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
- Class II
Drug Recall · May 28, 2024
Consumer Product Partners, LLC
Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-7505Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
- Class II
Drug Recall · May 28, 2024
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
- Class III
Drug Recall · May 28, 2024
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-Defective Container
- Class II
Drug Recall · May 28, 2024
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Class I
Drug Recall · May 28, 2024
Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
- Class III
Drug Recall · May 28, 2024
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-0Defective Container
- Class III
Drug Recall · May 28, 2024
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-0Defective Container
- Class I
Drug Recall · May 24, 2024
SYNCHRONICITY SPA INC, DBA SUNTE
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
- Class II
Drug Recall · May 23, 2024
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, MadeFailed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
- Class II
Drug Recall · May 23, 2024
Dr. Reddy's Laboratories, Inc.
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52Lack of Assurance of Sterility: Leaking vials
- Class III
Drug Recall · May 22, 2024
Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.