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Drug Recall Enforcement Reports

What are the Drug Enforcement Reports?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.

The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.

Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0592-202407-02-2024Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,
Package NDCs: 70710-1643-5; 70710-1643-7; 70710-1644-1; 70710-1644-5; 70710-1643-1		Cross contamination with other products.Zydus Pharmaceuticals (USA) Inc / 170,755 vialsClass IIIOngoing
D-0595-202407-02-2024Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).Cross contamination with other productsZydus Pharmaceuticals (USA) Inc / 12720 vialsClass IIICompleted
D-0601-202406-28-2024Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.Teva Pharmaceuticals USA, Inc / 116,144 bottlesClass IIOngoing
D-0612-202406-28-2024Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Package NDCs: 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05		Failed Dissolution Specifications: results below specificationsGlenmark Pharmaceuticals Inc., USA / a) 145,800 bottles; b) 1,368 bottlesClass IIOngoing
D-0600-202406-27-2024Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.Presence of particulate matter: glassZydus Pharmaceuticals (USA) Inc / 432250 vialsClass IITerminated
D-0625-202406-26-2024Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90
Package NDCs: 43598-478-01; 43598-478-90; 43598-479-01; 43598-479-90		Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packetsDr. Reddy's Laboratories, Inc. / 5,136 cartonsClass IIIOngoing
D-0611-202406-26-2024Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03CGMP Deviations: Out of specification for dissolutionRemedyRepack Inc. / 142 blister cards, 30 per blister cardClass IITerminated
D-0570-202406-26-2024Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.CGMP Deviations and Presence of Particulate Matter: GlassMedisca Inc. / 113 bottlesClass IICompleted
D-0666-202406-26-2024Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dalayurevda.com, Made in India, UPC: 042535355019Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.Guru Inc. / Class IIOngoing
D-0591-202406-26-2024Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, Inc
Package NDCs: 53228-003-01; 53228-002-01		CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.Equibal Inc / 90/1 oz. tubes and 248/4 oz. bottlesClass IITerminated
D-0619-202406-25-2024Potassium 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 Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.
Package NDCs: 68001-396-00; 68001-396-03		Failed Dissolution SpecificationsAmerisource Health Services LLC / 61,231 bottlesClass IOngoing
D-0616-202406-25-2024Hemp 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%.GLOBAL WIDGET LLC / 2082 bottlesClass IIIOngoing
D-0615-202406-25-2024Hemp 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%.GLOBAL WIDGET LLC / 11130 bottlesClass IIIOngoing
D-0614-202406-25-2024Nature'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%.GLOBAL WIDGET LLC / 2466 bottlesClass IIIOngoing
D-0613-202406-25-2024Hemp 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%.GLOBAL WIDGET LLC / 18540 bottlesClass IIIOngoing
D-0590-202406-24-2024buPROPion 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: 60687-782-01.
Package NDCs: 60687-782-11; 60687-782-01; 60687-793-11; 60687-793-21		Failed Dissolution Specifications; the product is dissolving faster than the specified limits.Amerisource Health Services LLC / 2,484 cartonsClass IIOngoing
D-0569-202406-24-2024SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.
Package NDCs: 13709-325-01		Sub-potent DrugNeilmed Pharmaceuticals Inc / 20,370 bottlesClass IIIOngoing
D-0599-202406-24-2024Diflorasone 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 64980-124-60
Package NDCs: 64980-124-15; 64980-124-03; 64980-124-45; 64980-124-60		Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.Rising Pharma Holding, Inc. / 868 tubesClass IIIOngoing
D-0631-202406-21-2024Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
Package NDCs: 50090-5313-1; 50090-5313-2; 50090-5313-3; 50090-5313-4; 50090-5313-5		Labeling: 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.A-S Medication Solutions LLC / 429 bottlesClass ITerminated
D-0617-202406-21-2024Venlafaxine 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 Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
Package NDCs: 68382-034-06; 68382-034-16; 68382-034-10; 68382-035-06; 68382-035-16; 68382-035-10; 68382-036-06; 68382-036-16; 68382-036-10		Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.Zydus Pharmaceuticals (USA) Inc / a) 13,128 bottles; b) 252 bottlesClass IITerminated
D-0575-202406-20-2024Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02; c) 4OZ (113G) glass jar, UPC Code 6 73673 88218 3, NDC 70722-229-04; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 1041Class IIOngoing
D-0577-202406-20-2024Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 320 metal tinsClass IIOngoing
D-0574-202406-20-2024Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 1264 glass jarsClass IIOngoing
D-0571-202406-20-2024Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 1654 glass jarsClass IIOngoing
D-0576-202406-20-2024Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ (85.05G) metal tin, UPC Code 6 73673 88208 4, NDC 70722-208-03; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 165 metal tinsClass IIOngoing
D-0572-202406-20-2024Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 788 glass jarsClass IIOngoing
D-0573-202406-20-2024Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 6,312 tin and glass jarsClass IIOngoing
D-0578-202406-20-2024Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 20 spray bottlesClass IIOngoing
D-0584-202406-18-2024Venlafaxine 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 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 864 cartonsClass IITerminated
D-0580-202406-18-2024Dodex 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 Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308Subpotent drug: out of specification resultsAccord Healthcare, Inc. / 52,998Class IIITerminated
D-0608-202406-18-2024DELFLEX 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-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
Package NDCs: 49230-206-92; 49230-206-94; 49230-206-95; 49230-209-92; 49230-209-94; 49230-209-95; 49230-212-92; 49230-212-94; 49230-212-95		This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.Fresenius Medical Care Holdings, Inc. / 183 casesClass IIOngoing
D-0587-202406-17-2024Dianeal 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 USA. NDC: 0941-0457-01
Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0427-52; 0941-0427-53; 0941-0429-52; 0941-0429-53; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0484-01; 0941-0487-01; 0941-0490-01		Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.Baxter Healthcare Corporation / 6,874 bagsClass IIOngoing
D-0579-202406-17-2024Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
Package NDCs: 13811-709-10; 13811-706-10; 13811-707-10; 13811-708-10; 13811-710-10; 13811-710-30		Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.Trigen Laboratories / 10,448 100-count bottlesClass IITerminated
D-0567-202406-12-2024Zilretta (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 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01
Package NDCs: 65250-003-01; 65250-001-01; 65250-002-01		Failed 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¿CPACIRA PHARMACEUTICALS INC / 40,517 kitsClass IIOngoing
D-0598-202406-10-2024Oatmeal 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, L3X 2S2, Made in Canada.Microbial Contamination of Non-Sterile Products: confirmed presence of mold contaminationBrands International Corporation / 120,319 bottlesClass IIOngoing
D-0583-202406-07-2024Allopurinol 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.
Package NDCs: 55111-729-01; 55111-729-10; 55111-730-01; 55111-730-05		Presence of foreign substance.Dr. Reddy's Laboratories, Inc. / 20,520 unitsClass IITerminated
D-0610-202406-05-2024STELLALIFE 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 69685-143-16
Package NDCs: 69685-143-16		Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organismHomeocare Laboratories, Inc. / 31,110 x 16 fl. oz. bottleClass IITerminated
D-0609-202406-05-2024STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01
Package NDCs: 69685-121-01		Microbial Contamination of Non-Sterile Products: multiple Bacillus species organismsHomeocare Laboratories, Inc. / 31,811 x 1 fl. oz. spray bottleClass ITerminated
D-0561-202406-04-2024Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34Subpotent DrugTeva Pharmaceuticals USA, Inc / 34,448 bottlesClass IIOngoing
D-0581-202406-04-2024Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30
Package NDCs: 55111-629-30; 55111-629-01; 55111-629-05; 55111-619-30; 55111-619-90; 55111-619-01; 55111-619-05; 55111-619-79; 55111-619-09; 55111-617-30; 55111-617-90; 55111-617-01; 55111-617-05; 55111-617-79; 55111-617-09		Failed Impurities/Degradation Specifications: Related SubstancesDr. Reddy's Laboratories, Inc. / 13,752 bottlesClass IIIOngoing
D-0549-202405-31-2024Phenazopyridine 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.RemedyRepack Inc. / 8 bottlesClass IITerminated
D-0618-202405-31-2024Complete 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.Washington Homeopathic Products, Inc. / 11 kitsClass IIITerminated
D-0604-202405-30-2024Potassium 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.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01
Package NDCs: 68462-357-90; 68462-357-01; 68462-357-05		Failed Dissolution SpecificationsGlenmark Pharmaceuticals Inc., USA / 285,840 bottlesClass IOngoing
D-0559-202405-30-2024Cefixime 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, Mandideep, India NDC 68180-407-03
Package NDCs: 68180-405-01; 68180-407-03; 68180-407-04; 68180-416-08; 68180-416-11; 68180-423-11; 68180-423-08		Failed Content Uniformity SpecificationsLupin Pharmaceuticals Inc. / 3,552 bottlesClass IITerminated
D-0605-202405-30-2024Potassium 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.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
Package NDCs: 68462-357-90; 68462-357-01; 68462-357-05		Failed Dissolution SpecificationsGlenmark Pharmaceuticals Inc., USA / 36,630 bottlesClass IOngoing
D-0606-202405-30-2024Potassium 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.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01
Package NDCs: 68462-357-90; 68462-357-01; 68462-357-05		CGMP DeviationsGlenmark Pharmaceuticals Inc., USA / Class IIOngoing
D-0607-202405-30-2024Potassium 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.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
Package NDCs: 68462-357-90; 68462-357-01; 68462-357-05		CGMP DeviationsGlenmark Pharmaceuticals Inc., USA / Class IIOngoing
D-0553-202405-28-2024Docetaxel 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
Package NDCs: 25021-254-08; 25021-254-16		Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.Sagent Pharmaceuticals / 762 vialsClass IOngoing
D-0552-202405-28-2024Asmanex 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 78206-0114-04Defective ContainerOrganon Llc / 0Class IIIOngoing
D-0554-202405-28-2024Docetaxel 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
Package NDCs: 25021-254-08; 25021-254-16		Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.Sagent Pharmaceuticals / 2806 vialsClass IOngoing
D-0557-202405-28-2024Little 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
Package NDCs: 63029-103-01; 63029-103-02		cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.Denison Pharmaceuticals, LLC / 113,544 bottlesClass IITerminated
D-0560-202405-28-2024Petroleum 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 0-72036-75051-8; CVS, with UPC 0-50428-31702-0
Package NDCs: 11822-3135-4; 11822-3135-2; 30142-069-07; 30142-069-27; 30142-069-54; 72036-069-27; 72036-069-54; 59779-069-27; 59779-069-54; 59779-069-18; 59779-069-96		Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and ChamomileConsumer Product Partners, LLC / 1015 casesClass IITerminated
D-0545-202405-28-2024Phenazopyridine 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,
Package NDCs: 75826-114-10; 75826-115-10		Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.Winder Laboratories, LLC / 473 cases (5676 Bottles)Class IICompleted
D-0551-202405-28-2024Asmanex 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 78206-114-03
Package NDCs: 78206-114-03; 78206-114-04; 78206-114-02; 78206-114-01; 78206-114-59; 78206-115-59; 78206-115-01		Defective ContainerOrganon Llc / 2,551 unitsClass IIIOngoing
D-0550-202405-28-2024Asmanex 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 78206-114-02
Package NDCs: 78206-114-03; 78206-114-04; 78206-114-02; 78206-114-01; 78206-114-59; 78206-115-59; 78206-115-01		Defective ContainerOrganon Llc / 2,886 unitsClass IIIOngoing
D-0589-202405-24-2024suntegrity, (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: 854245006170 - IVORY b) NDC: 69949-156-01, UPC: 854245006224 - NUDE c) NDC: 69949-152-01, UPC: 854245006187 - BUFF d) NDC: 69949-153-01, UPC: 854245006194 - SAND e) NDC: 69949-155-01, UPC: 854245006217 - BRONZE f) NDC: 69949-157-01, UPC: 854245006446 - MOCHA
Package NDCs: 69949-151-01; 69949-152-01; 69949-153-01; 69949-154-01; 69949-155-01; 69949-156-01; 69949-157-01; 8542450061; 8542450062; 8542450064		CGMP DeviationsSYNCHRONICITY SPA INC, DBA SUNTE / 8202 tubesClass IIOngoing
D-0588-202405-24-2024suntegrity, (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
Package NDCs: 69949-151-01; 69949-152-01; 69949-153-01; 69949-154-01; 69949-155-01; 69949-156-01; 69949-157-01; 8542450061		Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)SYNCHRONICITY SPA INC, DBA SUNTE / 1,902 tubesClass IOngoing
D-0555-202405-23-2024Dexamethasone 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 in India, NDC 55150-239-30
Package NDCs: 55150-237-01; 55150-238-05; 55150-239-30		Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.Eugia US LLC / 70,125 vialsClass IIOngoing
D-0510-202405-23-2024Zoledronic 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 vialsDr. Reddy's Laboratories, Inc. / 13,880 vialsClass IIOngoing
D-0558-202405-22-2024OSSOS-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. 53370Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,MexHealth LLC / 20 bottlesClass IIOngoing
D-0556-202405-22-2024Eptifibatide 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
Package NDCs: 55150-218-99; 55150-219-10; 55150-220-99		Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.Eugia US LLC / 15,500 single dose vialsClass IIIOngoing
D-0566-202405-20-2024Extra 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 309046730606
Package NDCs: 0904-6730-60; 0904-6730-80; 0904-6730-59; 0904-6730-61; 3090467306		Discoloration: Brownish tabletsContract Pharmacal Corporation / 14,616 bottlesClass IIOngoing
D-0565-202405-20-2024Labetalol 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., Lake Forest, IL 60045 USA. NDC: 0409-2339-24
Package NDCs: 0409-2339-24; 0409-2339-34		Lack of Assurance of Sterility-The potential for incomplete crimp seals.Pfizer Inc. / 220,400 cartridgesClass IIOngoing
D-0509-202405-20-2024Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Package NDCs: 50242-041-64; 50242-041-10		Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.Genentech, Inc. / Lot:3618858 = 105,759; Lot:3618873 =90,359Class IITerminated
D-0564-202405-20-2024Buprenorphine 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., Lake Forest, IL 60045 USA. NDC: 0409-2012-03
Package NDCs: 0409-2012-03; 0409-2012-32		Lack of Assurance of Sterility-The potential for incomplete crimp seals.Pfizer Inc. / 84,710 cartridgesClass IIOngoing
D-0562-202405-17-2024Duloxetine 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., Berkeley Heights, NJ 07922. NDC 51991-748-90
Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10		CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitBreckenridge Pharmaceutical, Inc / 165,678, 90-count bottlesClass IITerminated
D-0544-202405-17-2024Tivicay 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: ViiV Healthcare Durham, NC, 27701, By: GlaxoSmithKline Durham, NC 27701, NDC 49702-255-37Labeling: 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.GlaxoSmithKline LLC / 463 CartonsClass IIITerminated
D-0541-202405-16-2024Pregabalin 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 64980-411-10
Package NDCs: 64980-410-09; 64980-410-10; 64980-410-01; 64980-411-09; 64980-411-10; 64980-411-01; 64980-412-09; 64980-412-10; 64980-412-01; 64980-413-09; 64980-413-10; 64980-413-01; 64980-414-09; 64980-414-10; 64980-414-01; 64980-415-09; 64980-415-10; 64980-415-01; 64980-416-09; 64980-416-10; 64980-416-01; 64980-417-09; 64980-417-10; 64980-417-01		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.Rising Pharma Holding, Inc. / N/AClass IIIOngoing
D-0543-202405-16-2024Estradiol 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 08534, NDC 70710-1191-8
Package NDCs: 70710-1191-1; 70710-1191-8; 70710-1192-1; 70710-1192-8; 70710-1193-1; 70710-1193-8; 70710-1194-1; 70710-1194-8; 70710-1195-1; 70710-1195-8		Failed Impurities/Degradation Specifications.Zydus Pharmaceuticals (USA) Inc / 13,440 unitsClass IIIOngoing
D-0542-202405-16-2024Estradiol 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 08534, NDC 70710-1192-8
Package NDCs: 70710-1191-1; 70710-1191-8; 70710-1192-1; 70710-1192-8; 70710-1193-1; 70710-1193-8; 70710-1194-1; 70710-1194-8; 70710-1195-1; 70710-1195-8		Failed Impurities/Degradation Specifications.Zydus Pharmaceuticals (USA) Inc / 21,360 unitsClass IIIOngoing
D-0531-202405-15-2024EYLEA, (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 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54
Package NDCs: 61755-005-02; 61755-005-55; 61755-005-01; 61755-005-54; 8231500321; 8231500335; 8231500333; 8231500334; 8231500339; 8231500347; 8231500336; 8231500337; 8231500340; 8268700014		Lack of Assurance of Sterility: Complaints of syringe breakageRegeneron Pharmaceuticals Inc / 405,725 Prefilled syringesClass IITerminated
D-0512-202405-14-2024Epinephrine-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 71384-640-01Lack of Assurance of SterilityImprimis NJOF, LLC / 14,180 vialsClass IIOngoing
D-0548-202405-14-2024Prednisolone-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 71384-310-05Lack of Assurance of SterilityImprimis NJOF, LLC / 4,280 boxesClass IIOngoing
D-0513-202405-14-2024Dexamethasone-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 71384-512-01Lack of Assurance of SterilityImprimis NJOF, LLC / 39,700 vialsClass IIOngoing
D-0514-202405-14-2024Dexamethasone-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, Ledgewood, NJ 07852, NDC 71384-513-01Lack of Assurance of SterilityImprimis NJOF, LLC / 38,060 vialsClass IIOngoing
D-0519-202405-14-2024Epinephrine-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 71384-640-01Lack of Assurance of SterilityImprimis NJOF, LLC / 74,440 unitsClass IIOngoing
D-0547-202405-14-2024Klarity-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 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05Lack of Assurance of SterilityImprimis NJOF, LLC / 136,005 unitsClass IIOngoing
D-0515-202405-14-2024Moxifloxacin 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 71384-509-08Lack of Assurance of SterilityImprimis NJOF, LLC / 18,980 vialsClass IIOngoing
D-0516-202405-14-2024Moxifloxacin 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 71384-511-08Lack of Assurance of SterilityImprimis NJOF, LLC / 165,920 vialsClass IIOngoing
D-0503-202405-14-2024niCARdipine 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., New Albany, OH 43054. NDC 72572-470-10
Package NDCs: 72572-470-01; 72572-470-10		Lack of Assurance of Sterility.American Regent, Inc. / 4,136 cartons (10 vials in each carton)Class IITerminated
D-0507-202405-13-2024Vasopressin 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
Package NDCs: 0517-1020-01; 0517-1020-25; 0517-1030-01		Subpotent product in addition to having out-of-specification results for impurities.American Regent, Inc. / 2,352 vialsClass IITerminated
D-0568-202405-13-2024Duloxetine 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, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.Golden State Medical Supply Inc. / 21,655 (30 count bottle), 34,149 (90 count bottle)Class IITerminated
D-0535-202405-13-2024Rizatriptan 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
Package NDCs: 68462-467-74; 68462-467-46; 68462-467-06; 68462-468-74; 68462-468-46; 68462-468-06		CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.Glenmark Pharmaceuticals Inc., USA / 13296 cartonsClass IIOngoing
D-0534-202405-13-2024Rizatriptan 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
Package NDCs: 68462-467-74; 68462-467-46; 68462-467-06; 68462-468-74; 68462-468-46; 68462-468-06		CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.Glenmark Pharmaceuticals Inc., USA / 2400 cartonsClass IIOngoing
D-0538-202405-10-2024Cephalexin 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: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-8858-1.
Package NDCs: 63629-8858-1		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'Bryant Ranch Prepack, Inc. / 104 bottlesClass IIIOngoing
D-0532-202405-10-2024Rizatriptan 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
Package NDCs: 68462-465-72; 68462-465-99; 68462-466-72; 68462-466-99		CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.Glenmark Pharmaceuticals Inc., USA / 3,480 cartonsClass IIOngoing
D-0533-202405-10-2024Rizatriptan 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
Package NDCs: 68462-465-72; 68462-465-99; 68462-466-72; 68462-466-99		CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.Glenmark Pharmaceuticals Inc., USA / 11,976 cartonsClass IIOngoing
D-0505-202405-10-2024Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitPreferred Pharmaceuticals, Inc. / 66 bottles of 30 tabletsClass IIOngoing
D-0539-202405-10-2024Cephalexin 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, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9206-1.
Package NDCs: 63629-9206-1		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'Bryant Ranch Prepack, Inc. / 190 bottlesClass IIIOngoing
D-0537-202405-10-2024Cephalexin 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. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1.
Package NDCs: 63629-9205-1		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 5gBryant Ranch Prepack, Inc. / 6 bottlesClass IIIOngoing
D-0536-202405-10-2024Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.
Package NDCs: 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'Bryant Ranch Prepack, Inc. / 156 bottlesClass IIIOngoing
D-0540-202405-10-2024Cephalexin 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: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9207-1.
Package NDCs: 63629-9207-1		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'Bryant Ranch Prepack, Inc. / 61 BottlesClass IIIOngoing
D-0518-202405-08-2024Cefdinir 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, 462 046 India, NDC 68180-723-04
Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05		Defective container: lack of seal integrity.Lupin Pharmaceuticals Inc. / 51,006 bottlesClass IITerminated
D-0546-202405-07-2024Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01. Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01. Carton Label: Drug Vial Label: 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.
Package NDCs: 65250-003-01; 65250-001-01; 65250-002-01		Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.PACIRA PHARMACEUTICALS INC / 43,768 kitsClass IIOngoing
D-0498-202405-07-2024Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44
Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12		Presence of foreign substance: plastic-like substance.MACLEODS PHARMA USA, INC / 1,048 bottlesClass IIOngoing
D-0517-202405-06-2024Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
Package NDCs: 52817-362-10; 52817-362-00; 52817-359-10; 52817-359-50; 52817-361-10; 52817-361-00; 52817-360-10; 52817-360-00; 52817-358-10; 52817-358-50		Presence of Foreign Substance: metal in tabletRubicon Research Private Limited / 11,664 BottlesClass IIOngoing
D-0489-202405-02-2024TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadolRemedyRepack Inc. / 23,970 TabletsClass IITerminated
D-0500-202405-01-2024CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
Package NDCs: 51316-881-10		Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteriaPharma Nobis LLC / 120830Class IIOngoing
D-0501-202405-01-2024Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9
Package NDCs: 79481-0034-9		Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteriaPharma Nobis LLC / 24840Class IIOngoing
D-0504-202405-01-2024Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
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