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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 81–100 of 1,000 recalls

Class ITerminated

STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01

Homeocare Laboratories, Inc.

Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms

June 5, 2024 · DrugView details →
Class IOngoing

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05

Glenmark Pharmaceuticals Inc., USA

Failed Dissolution Specifications

May 30, 2024 · DrugView details →
Class IOngoing

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01

Glenmark Pharmaceuticals Inc., USA

Failed Dissolution Specifications

May 30, 2024 · DrugView details →
Class IOngoing

Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

Sagent Pharmaceuticals

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

May 28, 2024 · DrugView details →
Class IOngoing

Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

Sagent Pharmaceuticals

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

May 28, 2024 · DrugView details →
Class IOngoing

suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187

SYNCHRONICITY SPA INC, DBA SUNTE

Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

May 24, 2024 · DrugView details →
Class ICompleted

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

Hikma Injectables USA Inc

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

April 29, 2024 · DrugView details →
Class ITerminated

Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.

Stop Clopez Corp

Marketed Without An Approved NDA/ANDA

April 22, 2024 · DrugView details →
Class IOngoing

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 →
Class IOngoing

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 →
Class ITerminated

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.

AvKARE

Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.

March 28, 2024 · DrugView details →
Class IOngoing

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 →
Class IOngoing

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 →
Class ITerminated

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, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

Amneal Pharmaceuticals of New York, LLC

Superpotent Drug: Due to overfilling of drug powder

March 21, 2024 · DrugView details →
Class IOngoing

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 →
Class IOngoing

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 →
Class IOngoing

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 →
Class IOngoing

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 →
Class IOngoing

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 →
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