Over-the-counter & supplements recalls

Food & drug recall · FDASeptember 16, 2024Serious

AbbVie Inc. — Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube

Over-the-counter & supplements · AbbVie Inc. · 2,473,563 tubes affected

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

Food & drug recall · FDASeptember 11, 2024Serious

Zhejiang Jingwei Pharmaceutical Co., Ltd. — First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube

Over-the-counter & supplements · Zhejiang Jingwei Pharmaceutical Co., Ltd. · 295,164 tubes affected

Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ".

Food & drug recall · FDAAugust 30, 2024Serious

Glenmark Pharmaceuticals Inc., USA — Mupirocin Ointment, USP, 2%, 22 g, Rx only

Over-the-counter & supplements · Glenmark Pharmaceuticals Inc., USA · 2,031,480 ointments affected

Subpotent Drug

Food & drug recall · FDAAugust 9, 2024Serious

Direct Rx — Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621

Over-the-counter & supplements · Direct Rx · 1410 bottles affected

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

Food & drug recall · FDAAugust 8, 2024Serious

Preferred Pharmaceuticals, Inc. — Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.

Over-the-counter & supplements · Preferred Pharmaceuticals, Inc. · 266 bottles affected

Failed Impurities/Degradation Specifications - at 18-month Stability testing

Food & drug recall · FDAAugust 6, 2024Serious

Dr. Reddy's Laboratories, Inc. — IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per

Over-the-counter & supplements · Dr. Reddy's Laboratories, Inc. · 103,298 bottles affected

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…

Food & drug recall · FDAAugust 6, 2024Serious

Dr. Reddy's Laboratories, Inc. — IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets pe

Over-the-counter & supplements · Dr. Reddy's Laboratories, Inc. · 14940 bottles affected

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…

Food & drug recall · FDAAugust 6, 2024Serious

Dr. Reddy's Laboratories, Inc. — IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per b

Over-the-counter & supplements · Dr. Reddy's Laboratories, Inc. · 31,802 bottles affected

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification…

Food & drug recall · FDAAugust 5, 2024Serious

Zeco LLC — HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZE

Over-the-counter & supplements · Zeco LLC

CGMP Deviations: sterile water not used for production

Food & drug recall · FDAJuly 31, 2024Highest risk

Granules Pharmaceuticals Inc. — Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only

Over-the-counter & supplements · Granules Pharmaceuticals Inc. · 11,808 500-count Bottles affected

Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Food & drug recall · FDAJuly 18, 2024Highest risk

MAIN PRODUCTS INC — Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

Over-the-counter & supplements · MAIN PRODUCTS INC · 57, 340 bottles affected

Marketed without Approved NDA/ANDA.

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Food & drug recall · FDAJuly 18, 2024Labelling issue

Granules Consumer Health Inc. — Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton

Over-the-counter & supplements · Granules Consumer Health Inc. · 21,192 Bottles affected

Label mix-up: Carton incorrectly labeled.

Food & drug recall · FDAJuly 12, 2024Highest risk

Supercore Products Group Inc. — Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199

Over-the-counter & supplements · Supercore Products Group Inc. · 615 affected

Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Food & drug recall · FDAJuly 12, 2024Highest risk

SoloVital — Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

Over-the-counter & supplements · SoloVital · 1,331 bottles affected

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Food & drug recall · FDAJuly 12, 2024Highest risk

Supercore Products Group Inc. — Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30

Over-the-counter & supplements · Supercore Products Group Inc. · 729 affected

Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Food & drug recall · FDAJuly 11, 2024Highest risk

Aurobindo Pharma USA Inc — Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles

Over-the-counter & supplements · Aurobindo Pharma USA Inc · 240 bottles affected

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

Food & drug recall · FDAJuly 8, 2024Highest risk

Hikma Pharmaceuticals USA Inc. — Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only

Over-the-counter & supplements · Hikma Pharmaceuticals USA Inc. · 31,400 bags affected

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection…

Food & drug recall · FDAJune 26, 2024Serious

Equibal Inc — Blemfree 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

Over-the-counter & supplements · Equibal Inc · 90/1 oz. tubes and 248/4 oz. bottles affected

CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.

Food & drug recall · FDAJune 26, 2024Highest risk

Guru Inc. — Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules

Over-the-counter & supplements · Guru Inc.

Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Food & drug recall · FDAJune 24, 2024Labelling issue

Rising Pharma Holding, Inc. — 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 64980-124-60

Over-the-counter & supplements · Rising Pharma Holding, Inc. · 868 tubes affected

Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.