Drug Recalls
RSS ↗2,059 drug recalls from federal enforcement feeds.
Showing 1,751–1,800 of 2,059
- Class III
Drug Recall · April 10, 2024
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01Out of specification for assay
- Class III
Drug Recall · April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.Cross Contamination with Other Products
- Class III
Drug Recall · April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13Cross Contamination with Other Products
- Class III
Drug Recall · April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13Cross Contamination with Other Products
- Class III
Drug Recall · April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13Cross Contamination with Other Products
- Class I
Drug Recall · April 8, 2024
Dr. Reddy's Laboratories, Inc.
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 435Sub-potent Drug; powder discoloration associated with decreased potency
- Class I
Drug Recall · April 8, 2024
Dr. Reddy's Laboratories, Inc.
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.Sub-potent Drug; powder discoloration associated with decreased potency
- Class III
Drug Recall · April 2, 2024
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further dilutedLabeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
- Class III
Drug Recall · April 2, 2024
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDCLabeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
- Class II
Drug Recall · March 28, 2024
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 05Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
- Class I
Drug Recall · March 28, 2024
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
- Class III
Drug Recall · March 27, 2024
NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
- Class II
Drug Recall · March 26, 2024
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: CiShort fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
- Class II
Drug Recall · March 26, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product ofFailed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
- Class III
Drug Recall · March 25, 2024
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10Failed Impurities/Degradation Specifications
- Class II
Drug Recall · March 25, 2024
Amneal Pharmaceuticals of New York, LLC
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.Failed Dissolution Specifications
- Class I
Drug Recall · March 23, 2024
Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , ManChemical Contamination: Product manufactured with ethanol API that contains methanol
- Class I
Drug Recall · March 23, 2024
Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5Chemical Contamination: Product manufactured with ethanol API that contains methanol
- Class II
Drug Recall · March 22, 2024
IntegraDose Compounding Services LLC
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1Lack of Assurance of Sterility: leaking bags
- Class II
Drug Recall · March 22, 2024
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00Lack of assurance of sterility: bags have the potential to leak..
- Class I
Drug Recall · March 21, 2024
Amneal Pharmaceuticals of New York, LLC
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, DisSuperpotent Drug: Due to overfilling of drug powder
- Class I
Drug Recall · March 19, 2024
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'LMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
Samurai-X Honey 6800, UPC 2 56891 27553 3.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
Weiner Boner Honey, 12g packet, 100% Organic Formula.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/AMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class I
Drug Recall · March 19, 2024
libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Class II
Drug Recall · March 12, 2024
Hikma Pharmaceuticals USA Inc.
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
- Class II
Drug Recall · March 7, 2024
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North WaleFailed Dissolution Specifications
- Class II
Drug Recall · March 6, 2024
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
- Class II
Drug Recall · March 5, 2024
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
- Class II
Drug Recall · March 4, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15,CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Class II
Drug Recall · March 4, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, DCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Class I
Drug Recall · March 4, 2024
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 420Presence of Particulate Matter.
- Class III
Drug Recall · March 4, 2024
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20Cross Contamination with Other Products:(mycophenolate mofetil).
- Class II
Drug Recall · March 1, 2024
S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.Failed Stability Specifications
- Class II
Drug Recall · March 1, 2024
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03Failed Stability Specifications
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing FLack of Assurance of Sterility: Firm did not perform process validation.