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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 101–120 of 228 recalls

Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64

Revive Rx LLC dba Revive Rx Pharmacy

Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate

April 20, 2024 · DrugView details →

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.

Dr. Reddy's Laboratories, Inc.

Sub-potent Drug; powder discoloration associated with decreased potency

April 8, 2024 · DrugView details →

Class IOngoing

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 43598-097-30.

Dr. Reddy's Laboratories, Inc.

Sub-potent Drug; powder discoloration associated with decreased potency

April 8, 2024 · DrugView details →

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 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean.

Aruba Aloe Balm N.V.

Chemical Contamination: Product manufactured with ethanol API that contains methanol

March 23, 2024 · DrugView details →

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 5

Aruba Aloe Balm N.V.

Chemical Contamination: Product manufactured with ethanol API that contains methanol

March 23, 2024 · DrugView details →

Weiner Boner Honey, 12g packet, 100% Organic Formula.

Pyramids Wholesale Inc.

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

March 19, 2024 · DrugView details →

Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.

Pyramids Wholesale Inc.

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

March 19, 2024 · DrugView details →

Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557

Pyramids Wholesale Inc.

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

March 19, 2024 · DrugView details →

Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455

Pyramids Wholesale Inc.

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

March 19, 2024 · DrugView details →

Samurai-X Honey 6800, UPC 2 56891 27553 3.

Pyramids Wholesale Inc.

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

March 19, 2024 · DrugView details →

ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L

Pyramids Wholesale Inc.

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

March 19, 2024 · DrugView details →

HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A

Pyramids Wholesale Inc.

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

March 19, 2024 · DrugView details →

SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762

Pyramids Wholesale Inc.

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

March 19, 2024 · DrugView details →

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.

Pyramids Wholesale Inc.

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

March 19, 2024 · DrugView details →

libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.

Pyramids Wholesale Inc.

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

March 19, 2024 · DrugView details →

GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.

Pyramids Wholesale Inc.

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

March 19, 2024 · DrugView details →

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: 42023-206-01

Par Sterile Products LLC

Presence of Particulate Matter.

March 4, 2024 · DrugView details →

Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10

Eugia US LLC

Presence of Particulate Matter

February 15, 2024 · DrugView details →

Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com

Today The World

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

February 6, 2024 · DrugView details →

SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683

Today The World

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

February 6, 2024 · DrugView details →

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