Drug Recalls

2,059 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1,651–1,700 of 2,059

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.-D
CGMP Deviations
Class II
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.-D
Failed Dissolution Specifications
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.-D
Failed Dissolution 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.-D
CGMP Deviations
Class II
Drug Recall · May 28, 2024
Sagent Pharmaceuticals
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 25021-254-08
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I
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 0-72036-7505
Labeling: 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
Organon Llc
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 78206-114-0
Defective Container
Class III
Drug Recall · May 28, 2024
Denison Pharmaceuticals, LLC
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 63029-103-02
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Class II
Drug Recall · May 28, 2024
Organon Llc
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 III
Drug Recall · May 28, 2024
Winder Laboratories, LLC
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 II
Drug Recall · May 28, 2024
Sagent Pharmaceuticals
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 25021-254-08
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I
Drug Recall · May 28, 2024
Organon Llc
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 78206-114-0
Defective Container
Class III
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 854245006187
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Class I
Drug Recall · May 24, 2024
SYNCHRONICITY SPA INC, DBA SUNTE
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 85
CGMP Deviations
Class II
Drug Recall · May 23, 2024
Eugia US LLC
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, Made
Failed 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 55111-688-52
Lack of Assurance of Sterility: Leaking vials
Class II
Drug Recall · May 22, 2024
Eugia US LLC
Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Class III
Drug Recall · May 22, 2024
MexHealth LLC
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Class II
Drug Recall · May 20, 2024
Pfizer Inc.
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., L
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II
Drug Recall · May 20, 2024
Genentech, Inc.
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Class II
Drug Recall · May 20, 2024
Contract Pharmacal Corporation
Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730
Discoloration: Brownish tablets
Class II
Drug Recall · May 20, 2024
Pfizer Inc.
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc.,
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II
Drug Recall · May 17, 2024
GlaxoSmithKline LLC
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 tablets, one 30-mL dosing cup and one 10-mL oral dosing syringe, Rx Only, Mfd for: Vi
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Class III
Drug Recall · May 17, 2024
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berk
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II
Drug Recall · May 16, 2024
Rising Pharma Holding, Inc.
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 6498
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Class III
Drug Recall · May 16, 2024
Zydus Pharmaceuticals (USA) Inc
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08
Failed Impurities/Degradation Specifications.
Class III
Drug Recall · May 16, 2024
Zydus Pharmaceuticals (USA) Inc
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0
Failed Impurities/Degradation Specifications.
Class III
Drug Recall · May 15, 2024
Regeneron Pharmaceuticals Inc
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Ol
Lack of Assurance of Sterility: Complaints of syringe breakage
Class II
Drug Recall · May 14, 2024
Imprimis NJOF, LLC
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-
Lack of Assurance of Sterility
Class II
Drug Recall · May 14, 2024
Imprimis NJOF, LLC
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Le
Lack of Assurance of Sterility
Class II
Drug Recall · May 14, 2024
Imprimis NJOF, LLC
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 4
Lack of Assurance of Sterility
Class II
Drug Recall · May 14, 2024
Imprimis NJOF, LLC
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
Lack of Assurance of Sterility
Class II
Drug Recall · May 14, 2024
Imprimis NJOF, LLC
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
Lack of Assurance of Sterility
Class II
Drug Recall · May 14, 2024
American Regent, Inc.
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc.
Lack of Assurance of Sterility.
Class II
Drug Recall · May 14, 2024
Imprimis NJOF, LLC
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 7138
Lack of Assurance of Sterility
Class II
Drug Recall · May 14, 2024
Imprimis NJOF, LLC
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71
Lack of Assurance of Sterility
Class II
Drug Recall · May 14, 2024
Imprimis NJOF, LLC
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640
Lack of Assurance of Sterility
Class II
Drug Recall · May 13, 2024
American Regent, Inc.
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
Subpotent product in addition to having out-of-specification results for impurities.
Class II
Drug Recall · May 13, 2024
Glenmark Pharmaceuticals Inc., USA
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II
Drug Recall · May 13, 2024
Glenmark Pharmaceuticals Inc., USA
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II
Drug Recall · May 13, 2024
Golden State Medical Supply Inc.
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Bar
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Class II
Drug Recall · May 10, 2024
Bryant Ranch Prepack, Inc.
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Class III
Drug Recall · May 10, 2024
Glenmark Pharmaceuticals Inc., USA
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II
Drug Recall · May 10, 2024
Bryant Ranch Prepack, Inc.
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactu
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Class III
Drug Recall · May 10, 2024
Bryant Ranch Prepack, Inc.
Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabele
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Class III
Drug Recall · May 10, 2024
Bryant Ranch Prepack, Inc.
Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III
Drug Recall · May 10, 2024
Glenmark Pharmaceuticals Inc., USA
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II
Drug Recall · May 10, 2024
Bryant Ranch Prepack, Inc.
Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled b
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III
Drug Recall · May 10, 2024
Preferred Pharmaceuticals, Inc.
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II
Drug Recall · May 8, 2024
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 0
Defective container: lack of seal integrity.
Class II