The Recall Registry

Recall data checked 4 hours ago

Loading…

Home › All recalls › Prescription medicine

Category

Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

Or try another category

Highest riskSeriousWorth checkingLabelling issueTap any recall for the hazard and what to do

2,003 recalls · newest first

Food & drug recall · FDAAugust 11, 2023Serious

Baxter Healthcare Corporation — Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 094

Prescription medicine · Baxter Healthcare Corporation · 22,112 bags affected

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Food & drug recall · FDAAugust 10, 2023Labelling issue

Imprimis NJOF, LLC — Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.

Prescription medicine · Imprimis NJOF, LLC · 2,683 bottles affected

Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.

Food & drug recall · FDAAugust 9, 2023Serious

Ecometics, Inc. — YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown

Prescription medicine · Ecometics, Inc. · a) 5028 bottles; b) 9809 bottles affected

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Food & drug recall · FDAAugust 9, 2023Serious

Ecometics, Inc. — Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only

Prescription medicine · Ecometics, Inc. · 38,486 vials affected

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Food & drug recall · FDAAugust 9, 2023Serious

Ecometics, Inc. — Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5

Prescription medicine · Ecometics, Inc. · a) 9816 bottles; b) 10,776 bottles affected

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Food & drug recall · FDAAugust 9, 2023Serious

Ecometics, Inc. — AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials

Prescription medicine · Ecometics, Inc. · 92,967 vials affected

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Food & drug recall · FDAAugust 9, 2023Serious

Ecometics, Inc. — activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ.

Prescription medicine · Ecometics, Inc. · 32,583 bottles affected

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Food & drug recall · FDAAugust 9, 2023Serious

Ecometics, Inc. — ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4

Prescription medicine · Ecometics, Inc. · a) 52,879 bottles; b) 12,054 bottles affected

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Food & drug recall · FDAAugust 7, 2023Labelling issue

Advanced Accelerator Applications USA, Inc. — PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 070

Prescription medicine · Advanced Accelerator Applications USA,… · 10 affected

Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

Food & drug recall · FDAAugust 3, 2023Highest risk

APG SEVEN, INC — Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885

Prescription medicine · APG SEVEN, INC · 120 bottles affected

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for…

Food & drug recall · FDAAugust 2, 2023Serious

Parker Laboratories, Inc. — Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004

Prescription medicine · Parker Laboratories, Inc. · 40 affected

CGMP Deviations

Food & drug recall · FDAAugust 2, 2023Serious

Aurobindo Pharma USA Inc. — Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93

Prescription medicine · Aurobindo Pharma USA Inc. · 9,890 bottles affected

Failed dissolution specifications - results obtained were below spec average.

Food & drug recall · FDAAugust 2, 2023Serious

Parker Laboratories, Inc. — Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eld

Prescription medicine · Parker Laboratories, Inc. · 8 affected

CGMP Deviations

Food & drug recall · FDAAugust 2, 2023Serious

Parker Laboratories, Inc. — Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12)

Prescription medicine · Parker Laboratories, Inc. · 250 affected

CGMP Deviations

Food & drug recall · FDAAugust 2, 2023Serious

Parker Laboratories, Inc. — Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road

Prescription medicine · Parker Laboratories, Inc. · 50 affected

CGMP Deviations

Food & drug recall · FDAJuly 27, 2023Labelling issue

ALEMBIC PHARMACEUTICALS, INC. — Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only

Prescription medicine · ALEMBIC PHARMACEUTICALS, INC. · 82,400 bottles affected

Failed Impurities/Degradation Specifications

Food & drug recall · FDAJuly 21, 2023Serious

Aurobindo Pharma USA Inc. — Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only

Prescription medicine · Aurobindo Pharma USA Inc. · 48 bottles affected

cGMP deviations: Batch was released prior to approval.

Food & drug recall · FDAJuly 21, 2023Serious

Aurobindo Pharma USA Inc. — Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only

Prescription medicine · Aurobindo Pharma USA Inc. · 48 bottles affected

cGMP deviations: Batch was released prior to approval.

Food & drug recall · FDAJuly 18, 2023Labelling issue

Ascend Laboratories, LLC — Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only

Prescription medicine · Ascend Laboratories, LLC · 99,516 sachets affected

Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

Food & drug recall · FDAFebruary 23, 2023Serious

Nutraceutical Corporation — NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0

Prescription medicine · Nutraceutical Corporation · 1590 affected

CGMP Deviations: Raw material recalled by repackager, due to discoloration.