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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 81–100 of 214 recalls

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 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 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 IOngoing