Browse Drug Recalls
2,085 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,085 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 2,085 FDA drug recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 14, 2013 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Unit... | Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and c... | Class II | Hospira Inc. |
| Aug 14, 2013 | 72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in... | Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil | Class I | Fabscout Entertainment, Inc |
| Aug 13, 2013 | CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medic... | Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual... | Class II | Teva Pharmaceuticals USA, Inc. |
| Aug 12, 2013 | Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Fo... | Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials. | Class II | Hospira, Inc. |
| Aug 12, 2013 | J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 ho... | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined th... | Class I | Jack Rabbit, Inc |
| Aug 9, 2013 | All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd... | Lack of Assurance of Sterility | Class II | Specialty Compounding, LLC |
| Aug 9, 2013 | CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% ... | Non Sterility: Microbial contamination | Class I | Specialty Compounding, LLC |
| Aug 8, 2013 | Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-N... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bo... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physicia... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium... | LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 co... | Class II | Qualitest Pharmaceuticals |
| Aug 8, 2013 | Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Phar... | CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good ma... | Class II | Marlex Pharmaceuticals, Inc. |
| Aug 8, 2013 | Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 ... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 table... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physicia... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx onl... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx on... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per ... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bo... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg),... | LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 co... | Class II | Qualitest Pharmaceuticals |
| Aug 8, 2013 | Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per b... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-N... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 8, 2013 | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... | Class II | Novartis Pharmaceuticals Corp. |
| Aug 7, 2013 | Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 m... | Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorg... | Class III | Sandoz Incorporated |
| Aug 6, 2013 | Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and sim... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicon... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and sim... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg,... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, ... | Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10... | Class II | Teva Pharmaceuticals USA, Inc. |
| Aug 6, 2013 | Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and algi... | Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, W... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicon... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and algi... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple... | Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the ... | Class II | Showline Automotive Products, Inc. dba US Soaps... |
| Aug 5, 2013 | Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powde... | Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desme... | Class I | Bethel Nutritional Consulting, Inc |
| Aug 5, 2013 | Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear s... | Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-d... | Class I | Bethel Nutritional Consulting, Inc |
| Aug 2, 2013 | Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum S... | Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of... | Class II | Dr. Reddy's Laboratories, Inc. |
| Aug 2, 2013 | Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only,... | Subpotent | Class II | American Health Packaging |
| Aug 1, 2013 | Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Via... | Presence of particulate matter: characterized as thin colorless flakes that are visually and chem... | Class II | Nexus Pharmaceuticals Inc |
| Aug 1, 2013 | Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by ... | Labeling: Incorrect Package Insert; product packaged with outdated version of the insert | Class III | AbbVie Inc. |
| Aug 1, 2013 | BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bo... | Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making i... | Class I | CTV Best Group |
| Jul 31, 2013 | Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Ch... | Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this produ... | Class I | Healthy Life Chemistry Inc dba Purity First |
| Jul 31, 2013 | BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... | Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above appro... | Class III | Actavis Inc |
| Jul 31, 2013 | B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, ... | Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclare... | Class I | Healthy Life Chemistry Inc dba Purity First |
| Jul 30, 2013 | Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (N... | Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other U... | Class II | West-Ward Pharmaceutical Corp. |
| Jul 30, 2013 | Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10... | Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets | Class II | West-Ward Pharmaceutical Corp. |
| Jul 26, 2013 | B-12 REJUV 25 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
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.