Browse Drug Recalls

695 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 695 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 695 FDA drug recalls in PA.

Clear

Date	Product	Reason	Class	Firm
May 21, 2019	Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC:...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, ...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 ...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
Apr 22, 2019	Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured...	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in...	Class II	RemedyRepack Inc.
Apr 12, 2019	Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL ...	Subpotent Product: assay results for Amoxicillin were below the specification limits.	Class II	Teva Pharmaceuticals USA
Mar 14, 2019	Losartan 50mg Tablet, 30 count each blister card.	CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmace...	Class II	RemedyRepack Inc.
Mar 11, 2019	Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablet...	Subpotent Drug.	Class III	Teva Pharmaceuticals USA
Dec 19, 2018	Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged i...	Failed dissolution specifications	Class II	Teva Pharmaceuticals USA
Dec 11, 2018	Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: K...	Labeling: Wrong bar code	Class II	KVK-Tech, Inc.
Dec 10, 2018	Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as o...	Superpotent Drug: contains higher levels of Iron than labeled.	Class II	Gordon Laboratories
Nov 27, 2018	Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, ...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, ...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 27, 2018	Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-...	CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine...	Class II	Teva Pharmaceuticals USA
Nov 7, 2018	Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60...	Cross contamination with other products: Product is being recalled due to the potential presence ...	Class III	RemedyRepack Inc.
Oct 26, 2018	Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifes...	Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability...	Class III	RemedyRepack Inc.
Oct 19, 2018	Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, R...	Failed dissolution specifications: Out-of-Specification dissolution test result obtained during r...	Class II	Teva Pharmaceuticals USA
Oct 11, 2018	HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP...	CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for...	Class II	Lannett Company, Inc.
Sep 27, 2018	Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per...	Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine...	Class II	Teva Pharmaceuticals USA
Sep 21, 2018	Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only,...	Failed Disintegration Specifications: Out-of-specification disintegration test result obtained du...	Class II	Teva Pharmaceuticals USA
Sep 20, 2018	Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only...	Failed Stability Specifications: Out-of-specification test result for water content obtained duri...	Class II	Teva Pharmaceuticals USA
Sep 17, 2018	robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, ...	Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly...	Class I	Endo Pharmaceuticals, Inc.
Aug 24, 2018	Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in c...	CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act...	Class II	RemedyRepack Inc.
Aug 20, 2018	Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles ...	CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act...	Class II	RemedyRepack Inc.
Aug 10, 2018	Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, Reme...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	RemedyRepack Inc.
Aug 10, 2018	Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	RemedyRepack Inc.
Aug 10, 2018	Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	RemedyRepack Inc.
Aug 6, 2018	Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx...	Defective Delivery System: There is a potential for some tablets to be missing the laser drilling...	Class II	Teva Pharmaceuticals USA
Aug 6, 2018	PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Taked...	Defective Delivery System: There is a potential for some tablets to be missing the laser drilling...	Class II	Teva Pharmaceuticals USA
Aug 6, 2018	Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx...	Defective Delivery System: There is a potential for some tablets to be missing the laser drilling...	Class II	Teva Pharmaceuticals USA
Aug 6, 2018	Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, ...	Defective Delivery System: There is a potential for some tablets to be missing the laser drilling...	Class II	Teva Pharmaceuticals USA
Aug 6, 2018	Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(ND...	Defective Delivery System: There is a potential for some tablets to be missing the laser drilling...	Class II	Teva Pharmaceuticals USA
Aug 6, 2018	Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, R...	Defective Delivery System: There is a potential for some tablets to be missing the laser drilling...	Class II	Teva Pharmaceuticals USA
Aug 6, 2018	Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(ND...	Defective Delivery System: There is a potential for some tablets to be missing the laser drilling...	Class II	Teva Pharmaceuticals USA
Jul 25, 2018	Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laborator...	Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product...	Class II	Ranier's Compounding Laboratory
Jul 25, 2018	PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) I...	Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product...	Class II	Ranier's Compounding Laboratory
Jul 25, 2018	Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier'...	Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product...	Class II	Ranier's Compounding Laboratory
Jul 25, 2018	DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 ...	Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product...	Class II	Ranier's Compounding Laboratory
Jul 25, 2018	Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, ...	Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product...	Class II	Ranier's Compounding Laboratory
Jul 25, 2018	Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laborat...	Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product...	Class II	Ranier's Compounding Laboratory
Jul 25, 2018	PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, ...	Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product...	Class II	Ranier's Compounding Laboratory
Jul 25, 2018	Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laborator...	Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product...	Class II	Ranier's Compounding Laboratory
Jul 25, 2018	Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 m...	Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product...	Class II	Ranier's Compounding Laboratory
Jul 25, 2018	Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Labor...	Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product...	Class II	Ranier's Compounding Laboratory

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.