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
Jul 25, 2018 PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, ... 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 Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1... 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 P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/... 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 P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 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 Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 m... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 18, 2018 Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, R... Failed Tablet/Capsule Specifications: Tablet breakage Class II VENSUN PHARMACEUTICALS INC
Jul 18, 2018 Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, R... Failed Tablet/Capsule Specifications: Tablet breakage Class II VENSUN PHARMACEUTICALS INC
Jul 17, 2018 Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II RemedyRepack Inc.
Jul 17, 2018 Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II RemedyRepack Inc.
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, U... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bo... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Ma... API material used in the manufacturing of the product did not receive regulatory approval prior t... Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, U... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 16, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Teva Pharmaceuticals USA
Jul 5, 2018 Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, ... Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) t... Class II Teva Pharmaceuticals USA
May 16, 2018 screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g)... CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ... Class II Ideaz Llc
May 16, 2018 screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g... CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ... Class II Ideaz Llc
Apr 30, 2018 Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 pa... Failed Stability Specifications Class III Teva Pharmaceuticals USA
Apr 13, 2018 Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed... Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement o... Class III Boiron Inc.
Mar 19, 2018 Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0... Defective Container: This recall is being initiated due to product complaints regarding difficult... Class II Teva Pharmaceuticals USA
Feb 5, 2018 Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Isra... Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily reca... Class III Teva Pharmaceuticals USA
Jan 29, 2018 Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Jan 29, 2018 Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (ND... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Jan 29, 2018 Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Jan 29, 2018 Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (ND... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Dec 14, 2017 Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg,... Failed Impurities/Degradation Specifications: High out of specification test result for the Moexi... Class II Teva Pharmaceuticals USA
Nov 28, 2017 Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 1... Failed Impurities/Degradation Specifications: high out of specification test results obtained for... Class III Teva Pharmaceuticals USA
Nov 20, 2017 Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28... Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil a... Class II Teva Pharmaceuticals USA
Nov 9, 2017 Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Is... Failed Tablet/Capsule Specifications; potential presence of broken tablets. Class II Teva Pharmaceuticals USA
Oct 25, 2017 Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-co... Failed dissolution specifications; all lots within expiry are being recalled due to out of specif... Class II Teva Pharmaceuticals USA
Oct 17, 2017 Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only,... Failed Dissolution Specifications: Low out of specification results for dissolution. Class III Teva Pharmaceuticals USA
Sep 5, 2017 Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Ph... Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is ... Class II Teva Pharmaceuticals USA
Aug 22, 2017 Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-... Crystallization: Product is being recalled due to the manufacturer's recall due to the presence o... Class II RemedyRepack Inc.
Aug 3, 2017 Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10... Failed Impurities/Degradation Specifications: out-of-specification results obtained for individua... Class III KVK-Tech, Inc.
Aug 2, 2017 Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 3... Failed Moisture Limits: out of specification test results for water content obtained during stabi... Class III Teva Pharmaceuticals USA
Jul 25, 2017 Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 po... Failed Impurities/Degradation Specifications: high out of specification results for related compo... Class III Teva Pharmaceuticals USA
Jul 24, 2017 Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For:... Failed Tablet/Capsule Specification; out of specification for tablet weight Class II Teva Pharmaceuticals USA
Jun 29, 2017 Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle... Failed Impurities/Degradation Specifications: out of specification test results for related comp... Class III Teva Pharmaceuticals USA
Jun 29, 2017 Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bot... Failed Impurities/Degradation Specifications: out of specification test results for related comp... Class III Teva Pharmaceuticals USA
May 31, 2017 Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manuf... Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stab... Class I Teva Pharmaceuticals
Apr 24, 2017 Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count... Microbial Contamination of Non-Sterile Products Class II Teva Pharmaceuticals USA
Apr 19, 2017 Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz... GMP Deviations; product may not meet cGMP requirements Class II Gentell, Inc
Mar 28, 2017 PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL b... Failed Stability Specifications Class III Teva Pharmaceuticals USA
Feb 22, 2017 Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only,... Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance.... Class II Endo Pharmaceuticals, Inc.
Feb 17, 2017 Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... Failed Dissolution Specifications: low out of specification dissolution results found during stab... 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.