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.

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Date	Product	Reason	Class	Firm
Dec 22, 2022	BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innova...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, Rx Only, Pharmacy Innovations, 2...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENT...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0....	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFI...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/3...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	Acetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 293...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED ...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 20, 2022	Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma,...	Failed Impurities/Degradation specifications	Class II	RemedyRepack Inc.
Dec 5, 2022	Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 2315...	Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.	Class II	RemedyRepack Inc.
Nov 25, 2022	0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC ...	Lack of sterility assurance: Bags have the potential to leak.	Class II	B. Braun Medical, Inc.
Oct 21, 2022	Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharma...	Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.	Class II	Viatris Inc
Oct 7, 2022	Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Sy...	Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.	Class I	Viatris Inc
Sep 21, 2022	Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 ...	Presence of Particulate Matter: A complaint was received for the presence of a single strand of h...	Class II	Viatris Inc
Sep 16, 2022	Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT L...	Failed Viscosity specification: Slightly higher OOS results obtained for viscosity	Class III	ALMIRALL, LLC
Sep 15, 2022	Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, ...	Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.	Class II	RemedyRepack Inc.
May 24, 2022	Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formu...	Lack of Assurance of Sterility	Class II	US Specialty Formulations LLC
May 24, 2022	B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HC...	Lack of Assurance of Sterility	Class II	US Specialty Formulations LLC
May 4, 2022	Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repac...	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Class II	RemedyRepack Inc.
May 2, 2022	Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged ND...	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	Class II	RemedyRepack Inc.
May 2, 2022	Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC ...	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	Class II	RemedyRepack Inc.
Apr 28, 2022	Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx onl...	Failed Dissolution Specifications: low out of specification results for dissolution.	Class II	Viatris Inc
Apr 28, 2022	alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distr...	Failed Dissolution Specifications: low out-of-specification dissolution test results observed.	Class II	Viatris Inc
Apr 11, 2022	Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets ...	CGMP deviations: tablets cracking	Class II	Torrent Pharma Inc
Apr 6, 2022	Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1)...	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.	Class II	RemedyRepack Inc.
Feb 25, 2022	0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun...	Lack of sterility assurance: leaking bags	Class II	B. Braun Medical, Inc.
Feb 9, 2022	Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE ...	Failed Impurities/Degradation Specifications: Out of specification results for related substances.	Class II	Lannett Company, Inc.
Dec 30, 2021	Metformin 750 mg Extended Release NDC # 70518-2920-00	CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da...	Class II	RemedyRepack Inc.
Dec 29, 2021	Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b...	Failed Impurities/Degradation Specifications	Class II	RemedyRepack Inc.
Sep 21, 2021	Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bot...	Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained duri...	Class II	SigmaPharm Laboratories LLC
Sep 10, 2021	Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufac...	Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the...	Class II	Piramal Critical Care, Inc.
Aug 17, 2021	Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pen...	A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product w...	Class II	RemedyRepack Inc.
Aug 13, 2021	Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laborator...	Failed Impurities Specifications: Out of Specification impurity results obtained during routine t...	Class II	SigmaPharm Laboratories LLC
Jul 26, 2021	Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bott...	Marketed Without an Approved NDA/ANDA	Class II	High Performance Formulas, L.L.C. (HPF, L.L.C.)
Jul 2, 2021	Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By...	Temperature abuse: the firm received customer complaints of unusual grittiness in the product.	Class I	KVK-Tech, Inc.
May 13, 2021	Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium n...	Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluori...	Class II	Accupac, Inc.
Apr 27, 2021	Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 ...	Failed Impurities/Degradation Specifications	Class III	KVK-Tech, Inc.
Apr 19, 2021	Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laborato...	Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flav...	Class III	SigmaPharm Laboratories LLC
Apr 19, 2021	Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laborator...	Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flav...	Class III	SigmaPharm Laboratories LLC
Dec 23, 2020	Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, ...	Presence of Foreign Substance: Particulate matter was found in multiple lots of product.	Class III	Genus Lifesciences Inc.
Dec 18, 2020	Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, R...	Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide i...	Class III	KVK-Tech, Inc.
Nov 25, 2020	Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India f...	Failed Dissolution Specifications	Class I	Torrent Pharma Inc
Oct 11, 2020	Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx o...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	RemedyRepack Inc.

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.