Browse Drug Recalls
2,002 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,002 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 2,002 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 1, 2014 | Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Pac... | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... | Class I | American Health Packaging |
| 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 12, 2014 | Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bo... | Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary suppleme... | Class II | Thorne Research Inc |
| Jun 12, 2014 | Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles... | Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary suppleme... | Class II | Thorne Research 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 |
| Jun 2, 2014 | Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808 | Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked i... | Class II | Unit Dose Solutions Inc |
| Jun 2, 2014 | Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only... | Presence of Particulate Matter: Product failed the appearance for the presence of visible particl... | Class I | Alexion Pharmaceuticals, Inc. |
| 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 16, 2014 | ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syring... | Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine ... | Class II | US Compounding Inc |
| 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 29, 2014 | Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials... | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes d... | Class II | Flawless Beauty LLC |
| Apr 29, 2014 | Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per... | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates ... | Class II | Flawless Beauty LLC |
| Apr 29, 2014 | Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable ... | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates ... | Class II | Flawless Beauty LLC |
| Apr 29, 2014 | Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.... | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes d... | Class II | Flawless Beauty LLC |
| Apr 29, 2014 | Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 1... | Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. | Class II | Flawless Beauty LLC |
| Apr 29, 2014 | Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules... | Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling... | Class II | Flawless Beauty LLC |
| Apr 21, 2014 | Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx ... | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Class I | Pharmakon Pharmaceuticals |
| 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 | 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 | Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10)... | Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Rele... | Class II | Legacy Pharmaceutical Packaging |
| 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 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (4... | Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown... | Class II | Hi-Tech Pharmacal Co., 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 25, 2014 | MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged ... | Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER... | Class I | New Life Nutritional Center |
| Mar 25, 2014 | Esmeralda, bottle contains 30 Softgels, product is packaged in a white plasti... | Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER... | Class I | New Life Nutritional Center |
| 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 17, 2014 | Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial... | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | Class III | John W Hollis Inc |
| Mar 17, 2014 | Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, N... | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | Class II | John W Hollis Inc |
| Mar 17, 2014 | Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Ph... | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | Class III | John W Hollis Inc |
| Mar 3, 2014 | Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only... | Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the P... | Class III | Novartis Pharmaceuticals Corp. |
| Mar 3, 2014 | Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only... | Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the P... | Class III | Novartis Pharmaceuticals Corp. |
| Feb 20, 2014 | Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 coun... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vi... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 coun... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vi... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 coun... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count ... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 14, 2014 | CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals... | Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrullin... | Class I | Medisca Inc |
| Feb 7, 2014 | Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephed... | Defective Container: An unacceptable level of blister defects have been identified in Loratadine ... | Class II | Ohm Laboratories, Inc. |
| Jan 29, 2014 | Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E... | Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% ra... | Class III | Fougera Pharmaceuticals Inc. |
| Jan 28, 2014 | Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution... | Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatu... | Class II | RX South LLC DBA RX3 Pharmacy |
| Jan 22, 2014 | Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per... | Subpotent; 18 month time point | Class II | Fresenius Kabi USA, LLC |
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.