Over-the-counter & supplements recalls

Food & drug recall · FDADecember 12, 2024Labelling issue

Akron Pharma, Inc. — Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.

Over-the-counter & supplements · Akron Pharma, Inc. · 768 bottles affected

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Food & drug recall · FDADecember 12, 2024Labelling issue

Akron Pharma, Inc. — Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma

Over-the-counter & supplements · Akron Pharma, Inc. · 14825 bottles affected

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Food & drug recall · FDANovember 14, 2024Serious

LNK International, Inc. — Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pa

Over-the-counter & supplements · LNK International, Inc. · 288 cases x 30 8,640 boxes affected

CGMP Deviations: Released product should have been rejected.

Food & drug recall · FDANovember 14, 2024Highest risk

MXBBB — UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323

Over-the-counter & supplements · MXBBB · 321 bottles affected

cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and…

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 · FDANovember 11, 2024Serious

Safecor Health, LLC — Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01

Over-the-counter & supplements · Safecor Health, LLC · 7488 boxes affected

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Food & drug recall · FDANovember 11, 2024Serious

Safecor Health, LLC — Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01

Over-the-counter & supplements · Safecor Health, LLC · 1470 boxes affected

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Food & drug recall · FDANovember 11, 2024Serious

Safecor Health, LLC — Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01

Over-the-counter & supplements · Safecor Health, LLC · 3139 boxes affected

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Food & drug recall · FDANovember 6, 2024Highest risk

Trinity Gold Nutrition — Trinity Gold Nutrition, 60 Capsule, 30 day Supply

Over-the-counter & supplements · Trinity Gold Nutrition · 150 affected

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 · FDANovember 6, 2024Serious

Midlab Incorporated — Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L)

Over-the-counter & supplements · Midlab Incorporated

cGMP Deviations: Out of specification results for micro in hand soap products.

Food & drug recall · FDANovember 4, 2024Highest risk

Boulla LLC — VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons

Over-the-counter & supplements · Boulla LLC · Unknown affected

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

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 · FDANovember 4, 2024Highest risk

Boulla LLC — ZoomMax Capsules, 500 mg, 10 count blisters in cartons

Over-the-counter & supplements · Boulla LLC · Unknown affected

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

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 · FDANovember 4, 2024Highest risk

Boulla LLC — PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons

Over-the-counter & supplements · Boulla LLC · Unknown affected

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

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 · FDANovember 4, 2024Highest risk

Boulla LLC — ZapMax Capsules, 500 mg, 10 count blisters in cartons

Over-the-counter & supplements · Boulla LLC · Unknown affected

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

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 · FDAOctober 29, 2024Labelling issue

Dr. Reddy's Laboratories, Inc. — IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05

Over-the-counter & supplements · Dr. Reddy's Laboratories, Inc. · 3416 botttles affected

Failed Tablet/Capsule Specifications

Food & drug recall · FDAOctober 15, 2024Serious

Akron Pharma, Inc. — OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma

Over-the-counter & supplements · Akron Pharma, Inc. · 10845 bottles affected

CGMP Deviations

Food & drug recall · FDAOctober 8, 2024Highest risk

C & A Naturistics — AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg

Over-the-counter & supplements · C & A Naturistics · Unknown affected

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

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 · FDASeptember 24, 2024Serious

Glenmark Pharmaceuticals Inc., USA — Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328

Over-the-counter & supplements · Glenmark Pharmaceuticals Inc., USA · 45,504 bottles affected

Defective Delivery System: The dip tube is clogged causing the spray not to work.

Food & drug recall · FDASeptember 18, 2024Highest risk

123Herbals — Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.

Over-the-counter & supplements · 123Herbals · unknown affected

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.

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 · FDASeptember 18, 2024Serious

EnviroServe Chemicals Inc. — EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1

Over-the-counter & supplements · EnviroServe Chemicals Inc. · 120 bottles affected

CGMP deviations

Food & drug recall · FDASeptember 16, 2024Serious

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

Over-the-counter & supplements · AbbVie Inc. · 763,426 tubes affected

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