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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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DateProductReasonClassFirm
Feb 7, 2017 Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottle... Failed Impurities/Degradation Specifications Class II Teva Pharmaceuticals USA
Feb 7, 2017 Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsi... Failed Dissolution Specifications Class II RemedyRepack Inc.
Feb 2, 2017 Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 2... Failed Impurities/Degradation Specifications: out of specification test results for the norethin... Class II Teva Pharmaceuticals USA
Dec 21, 2016 Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bo... Subpotency: due to a low, out of specification test result for assay during stability testing. Class II Teva Pharmaceuticals USA
Dec 15, 2016 Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-... CGMP Deviations Class II Gentell, Inc
Dec 15, 2016 Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell... CGMP Deviations Class II Gentell, Inc
Dec 1, 2016 Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... Failed Dissolution Specifications Class III Teva Pharmaceuticals USA
Nov 23, 2016 Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count b... Marketed without an approved NDA/ANDA for which safety and efficacy has not been established. Class I Jeffreys Drug Store
Nov 1, 2016 Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, ... Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... Class III Teva Pharmaceuticals USA
Nov 1, 2016 Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, ... Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... Class III Teva Pharmaceuticals USA
Sep 22, 2016 PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pha... Failed Impurities/Degradation Specifications: out of specification test results for impurities du... Class III Teva Pharmaceuticals USA
Sep 22, 2016 PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pha... Failed Impurities/Degradation Specifications: out of specification test results for impurities du... Class III Teva Pharmaceuticals USA
Sep 22, 2016 PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pha... Failed Impurities/Degradation Specifications: out of specification test results for impurities du... Class III Teva Pharmaceuticals USA
Sep 13, 2016 mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multip... Failed Impurities/Degradation Specifications: potential failure to meet the specification for Imp... Class III Teva Pharmaceuticals USA
Sep 2, 2016 Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx On... Presence of Foreign Tablets/Capsules Class III Shire
Aug 5, 2016 Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 ... Failed Impurities/Degradation Specifications. Class III Teva North America
Jul 29, 2016 Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured ... CGMP Deviations Class II Teva Pharmaceuticals USA
Jul 29, 2016 Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufacture... CGMP Deviations Class II Teva Pharmaceuticals USA
Jul 15, 2016 Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg p... Failed Content Uniformity Specifications: out of specification test result for spray content unif... Class III Teva North America
Jun 24, 2016 Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Man... Superpotent drug: Out of specification test result for assay during stability testing. Class II Teva North America
Jun 22, 2016 Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in ... Presence of Foreign Substance; presence of black particles describes generically as cellulose-bas... Class II Teva North America
Jun 17, 2016 Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hun... CGMP Deviations Class II Teva North America
Jun 17, 2016 Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intrave... CGMP Deviations Class II Teva North America
Jun 17, 2016 Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA P... CGMP Deviations Class II Teva North America
Jun 17, 2016 ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Onl... CGMP Deviations Class II Teva North America
May 31, 2016 mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multip... Failed Impurities/Degradation Specifications: High out of specification results for Impurity D. Class III Teva North America
May 18, 2016 Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles,... Failed Tablet/Capsule Specifications Class III Teva North America
May 5, 2016 Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by:... Discoloration: presence of scuffing marks on tablets. Class III KVK-Tech, Inc.
Apr 27, 2016 Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-3... Lack of Assurance of Sterility: Due to potential for leaking bags. Class II Teva North America
Mar 9, 2016 Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manu... Presence of Particulate Matter: particulate matter identified as glass in one vial. Class I Teva Pharmaceuticals USA
Feb 12, 2016 Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 4... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 1... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 1... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, A... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 4... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only,... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bo... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 5, 2016 Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By... Failed Impurities/Degradation Specifications: Out of specification test results for impurities du... Class II Teva Pharmaceuticals USA
Dec 23, 2015 La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufac... Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... Class I Bee Xtreme
Dec 23, 2015 Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured f... Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... Class I Bee Xtreme
Dec 23, 2015 Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for... Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolp... Class I Bee Xtreme
Dec 21, 2015 Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bo... Failed Dissolution Specifications: low test results at the 18 month time-point Class II Teva North America
Dec 17, 2015 Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 f... Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result de... Class III Bio-pharm, Inc.
Nov 19, 2015 NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industri... Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. Class III Teva Pharmaceuticals USA

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.