NoticeMedications
Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus,
American Health Packaging
Presence of Foreign Tablets/Capsules
Source: FDA Drug Enforcement (openFDA API)
Medication Recalls
50 recalls— updated every few hours from the FDA's drug enforcement database.
About Medication Recalls
Medication recalls are issued when a prescription or over-the-counter drug is found to be defective, contaminated, or otherwise unsafe. The FDA's Center for Drug Evaluation and Research (CDER) oversees drug recalls in the United States and maintains the enforcement action database that powers this page.
Common causes of drug recalls include microbial or chemical contamination during manufacturing, incorrect potency (meaning a dose contains more or less of the active ingredient than labeled), labeling errors that could lead to medication errors, the presence of foreign particles or sub-potent ingredients, and products that fail sterility testing. In some cases, recalls occur because a facility failed to meet Good Manufacturing Practice (GMP) standards, even if no specific product defect has been identified yet.
Drug recalls are classified the same way as food recalls. A Class I recall means there is a reasonable probability that using the product will cause or lead to serious adverse health consequences or death — for example, a blood pressure medication with no active ingredient, or an injectable drug contaminated with bacteria. A Class II recall covers products that may cause temporary, reversible health effects. A Class III recall involves products that are unlikely to cause harm but violate FDA regulations.
If you take a recalled medication, do not stop taking a prescription without speaking to your doctor or pharmacist first — abruptly discontinuing some medications can be dangerous. Bring the recalled product to your pharmacy; they can check lot numbers and arrange a replacement. Never flush medication down the toilet unless the recall notice specifically instructs you to. Use the FDA's drug take-back program or an approved disposal method.
Important: Always consult your doctor or pharmacist before stopping or switching any prescription medication, even if it has been recalled. Your health provider can advise on the safest course of action.
NoticeMedications
Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd
Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications.
NoticeMedications
Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Par
Teva Pharmaceuticals USA, Inc
Presence of Foreign Tablets/Capsules
NoticeMedications
Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., I
Preferred Pharmaceuticals, Inc.
Failed Content Uniformity Specifications
NoticeMedications
Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220,
Houston Rx LLC
Lack of process control
Voluntary RecallMedications
Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Phar
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications
Voluntary RecallMedications
Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. b
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications
Voluntary RecallMedications
Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dis
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications
NoticeMedications
Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE
Houston Rx LLC
Lack of assurance of sterility.
NoticeMedications
Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC
Apothecary Pharma LLC
Lack of Assurance of Sterility
NoticeMedications
Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Car
Apothecary Pharma LLC
Lack of Assurance of Sterility
NoticeMedications
IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Di
J&J INNOVATIVE MEDICINE
Presence of particulate matter.
NoticeMedications
Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, C
Apotex Corp.
Failed dissolution specifications.
NoticeMedications
Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only
Cipla USA, Inc.
Failed Impurities/Degradation Specifications
NoticeMedications
amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Te
Aurobindo Pharma USA Inc
Discoloration: consumer complaints received for discolored tablets
NoticeMedications
FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Man
Aurolab Trust
Lack of Assurance of Sterility
NoticeMedications
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater
Ajanta Pharma USA Inc
Failed Dissolution Specifications: below specification
NoticeMedications
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Lack of Assurance of Sterility
NoticeMedications
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Lack of Assurance of Sterility
NoticeMedications
Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 4
K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
NoticeMedications
Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL
K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
NoticeMedications
Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl o
K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
NoticeMedications
Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) P
K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
NoticeMedications
Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Excha
K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
NoticeMedications
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best
K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
NoticeMedications
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIB
K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
NoticeMedications
Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryne
K.C. Pharmaceuticals, Inc.
Lack of Assurance of Sterility
NoticeMedications
QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosa
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
NoticeMedications
TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on do
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
NoticeMedications
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
NoticeMedications
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
NoticeMedications
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on d
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
NoticeMedications
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per sp
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
NoticeMedications
Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
NoticeMedications
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on d
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
NoticeMedications
TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on do
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
NoticeMedications
TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on do
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
NoticeMedications
TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on do
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
NoticeMedications
TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
NoticeMedications
SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dos
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
NoticeMedications
SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on do
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
NoticeMedications
SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
NoticeMedications
SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per sp
Carolina Infusion, LLC
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
NoticeMedications
Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, N
Amneal Pharmaceuticals, LLC
Defective Container; packets were found to be either empty or partially full.
NoticeMedications
Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malve
Par Health USA, LLC
Crystallization
NoticeMedications
Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, In
Pfizer
Lack of Assurance of Sterility
NoticeMedications
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City L
OurPharma LLC
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
NoticeMedications
Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC
Inventia Healthcare Limited
Failed Dissolution Specifications
NoticeMedications
Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bot
SV Labs Toronto Corporation
Microbial contamination of topical product.
NoticeMedications
Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite
SV Labs Toronto Corporation
Microbial contamination of topical product.