Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 5, 2014 | Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass... | Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl im... | Class III | Akorn, Inc. |
| Jul 30, 2014 | Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL... | Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval a... | Class III | Pfizer Inc. |
| Jul 30, 2014 | Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, M... | Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making... | Class III | Novartis Pharmaceuticals Corp. |
| Jul 28, 2014 | OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx onl... | Failed Stability Specifications: Out of specification result for preservative sodium benzoate. | Class III | Boehringer Ingelheim Roxane Inc |
| Jul 17, 2014 | Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, ... | Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each m... | Class III | X-Gen Pharmaceuticals Inc. |
| Jul 14, 2014 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, R... | Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzo... | Class III | Wockhardt Usa Inc. |
| Jul 11, 2014 | Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (... | Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... | Class III | Sandoz Inc |
| Jul 8, 2014 | VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only... | Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect ex... | Class III | Pfizer Inc. |
| Jul 3, 2014 | Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermat... | Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet s... | Class III | Fougera Pharmaceuticals Inc. |
| Jul 3, 2014 | Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules... | Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Jul 3, 2014 | Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatol... | Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet s... | Class III | Fougera Pharmaceuticals Inc. |
| Jul 2, 2014 | E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manu... | Subpotent Drug: Low out of specification results for both pH and assay obtained during routine st... | Class III | Bracco Diagnostic Inc |
| Jun 26, 2014 | LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guai... | Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, an... | Class III | Poly Pharmaceuticals, Inc |
| Jun 26, 2014 | POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Ma... | Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, an... | Class III | Poly Pharmaceuticals, Inc |
| Jun 20, 2014 | Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint F... | Failed Impurity/Degradation Specification; 12-month stability time point | Class III | Novel Laboratories, Inc. |
| Jun 20, 2014 | Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharma... | Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities. | Class III | Mylan Pharmaceuticals Inc. |
| Jun 19, 2014 | Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. ... | Failed Dissolution Specification; at the 12 month time interval. | Class III | Mckesson Packaging Services |
| Jun 19, 2014 | Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottl... | Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications f... | Class III | Pfizer Inc. |
| Jun 19, 2014 | Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx on... | Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... | Class III | Mylan Pharmaceuticals Inc. |
| Jun 17, 2014 | Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.... | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Class III | Teva Pharmaceuticals USA |
| Jun 17, 2014 | Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyc... | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Class III | Teva Pharmaceuticals USA |
| Jun 17, 2014 | Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 ... | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Class III | Teva Pharmaceuticals USA |
| Jun 17, 2014 | Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15... | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Class III | Teva Pharmaceuticals USA |
| Jun 6, 2014 | DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorop... | Stability Data Does Not Support Expiry | Class III | Estee Lauder Inc |
| Jun 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-co... | Labeling: Incorrect or Missing Package Insert | Class III | Valeant Pharmaceuticals North America LLC |
| Jun 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-co... | Labeling: Incorrect or Missing Package Insert | Class III | Valeant Pharmaceuticals North America LLC |
| Jun 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count... | Labeling: Incorrect or Missing Package Insert | Class III | Valeant Pharmaceuticals North America LLC |
| May 28, 2014 | Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule... | Failed Stability Specification; out of specification result for particle size distribution during... | Class III | Novartis Pharmaceuticals Corp. |
| May 21, 2014 | Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-... | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... | Class III | Valeant Pharmaceuticals North America LLC |
| May 21, 2014 | Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmac... | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... | Class III | Valeant Pharmaceuticals North America LLC |
| May 14, 2014 | Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distribu... | Labeling: Missing Label; The label on the immediate bottle is missing. | Class III | Oasis Medical Inc |
| Apr 25, 2014 | PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg an... | Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution | Class III | Prestige Brands Holdings |
| Apr 25, 2014 | PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextrometh... | Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution | Class III | Prestige Brands Holdings |
| Apr 18, 2014 | Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manu... | Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. | Class III | Apotex Corp. |
| Apr 17, 2014 | Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-... | Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long te... | Class III | Wockhardt Usa Inc. |
| Apr 17, 2014 | Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trig... | Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 mic... | Class III | Trigen Laboratories, Inc. |
| Apr 15, 2014 | Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl an... | Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. | Class III | P&L Developments, LLC |
| Apr 14, 2014 | HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi... | Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperid... | Class III | Fresenius Kabi USA LLC |
| Apr 14, 2014 | Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorph... | Subpotent Drug: Phenylephrine component is subpotent. | Class III | P&L Developments, LLC |
| Apr 14, 2014 | Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufacture... | Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the p... | Class III | Upsher Smith Laboratories, Inc. |
| Apr 11, 2014 | Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dex... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Apr 9, 2014 | Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufac... | Failed Impurities/Degradation Specifications: out of specification results for impurities/degrada... | Class III | Caraco Pharmaceutical Laboratories, Ltd. |
| Apr 9, 2014 | Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle... | Failed Impurities/Degradation Specifications: out of specification results for impurities/degrada... | Class III | Caraco Pharmaceutical Laboratories, Ltd. |
| Apr 4, 2014 | Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laborator... | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... | Class III | Boehringer Ingelheim Roxane Inc |
| Apr 4, 2014 | Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laborato... | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... | Class III | Boehringer Ingelheim Roxane Inc |
| Apr 1, 2014 | Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 F... | Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone... | Class III | Genesis Pharmaceutical, Inc. |
| Apr 1, 2014 | PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Kon... | Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. | Class III | Konsyl Pharmaceuticals Inc |
| Mar 27, 2014 | Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spi... | Defective Delivery System: Potential for dose delivery out of specification due to interation of ... | Class III | Boehringer Ingelheim Roxane Inc |
| Mar 25, 2014 | Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, R... | Labeling; Missing label; ampoules are missing the immediate container label | Class III | Hospira Inc. |
| Mar 20, 2014 | Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Ap... | Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 mont... | Class III | Apotex 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.