Browse Drug Recalls
2,021 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,021 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 2,021 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 15, 2012 | AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 ... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid... | Class III | Valeant Pharmaceuticals |
| Sep 28, 2012 | Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%)... | CGMP Deviations: The products were manufactured with raw material which contain unknown particles... | Class III | ITW Dymon |
| Sep 27, 2012 | CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-co... | Short Fill: some bottles contained less than 120-count per labeled claim. | Class III | Genentech, Inc. |
| Sep 21, 2012 | Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO... | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... | Class II | American Enterprises LLC dba Sterling Gelatin |
| Sep 4, 2012 | Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, ... | Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. | Class III | Apace KY LLC |
| Aug 28, 2012 | I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, O... | Lack of Assurance of Sterility: The product is being recalled because the product label does not ... | Class II | James G. Cole, Inc. |
| Aug 28, 2012 | Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metere... | Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indica... | Class II | Dispensing Solutions, Inc |
| Aug 27, 2012 | Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information ... | Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets beca... | Class I | Samantha Lynn, Inc |
| Aug 23, 2012 | Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Dist... | Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules." | Class III | Stat Rx USA |
| Aug 23, 2012 | Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUS... | Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warn... | Class III | Ferring Pharmaceuticals Inc |
| Aug 15, 2012 | HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject pr... | Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfille... | Class I | Hospira Inc. |
| Aug 7, 2012 | Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactu... | Cross Contamination w/Other Products: During stability testing chromatographic review revealed ex... | Class II | Mylan Pharmaceuticals Inc. |
| Jul 30, 2012 | Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solutio... | Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels... | Class III | Mallinckrodt Inc |
| Jul 25, 2012 | Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, R... | Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly... | Class III | American Health Packaging |
| Jul 25, 2012 | Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | Subpotent; 9-month stability interval | Class II | Lloyd Inc. of Iowa |
| Jul 25, 2012 | Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | Subpotent; 9-month stability interval | Class II | Lloyd Inc. of Iowa |
| Jul 23, 2012 | Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , M... | Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (A... | Class III | Stat Rx USA |
| Jul 23, 2012 | Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters pe... | Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratori... | Class II | American Health Packaging |
| Jul 18, 2012 | Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Ace... | Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free ... | Class II | LNK International, Inc. |
| Jul 18, 2012 | Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & C... | Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary... | Class III | Fougera Pharmaceuticals Inc. |
| Jul 16, 2012 | X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 1... | Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sil... | Class I | Coral Rock Man, Inc. |
| Jul 13, 2012 | CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g... | Microbial Contamination of Non Sterile Product; mold | Class II | Island Kinetics dba Covalence |
| Jul 12, 2012 | Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 m... | Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packagi... | Class III | Axcentria Pharmaceuticals LLC |
| Jul 9, 2012 | Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 6, 2012 | NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufact... | Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90... | Class II | Glenmark Generics Inc., USA |
| Jun 28, 2012 | Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 dose... | Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Fact... | Class III | Health Plus Incorporated |
| Jun 27, 2012 | Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplas... | The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, a... | Class II | Hospira Inc. |
| Jun 18, 2012 | Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only... | Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "oi... | Class III | Stat Rx USA |
| Jun 14, 2012 | Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.... | Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufact... | Class II | Dukal Corp. |
| Jun 5, 2012 | Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi... | Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly... | Class II | Bristol-myers Squibb Company |
| Jun 5, 2012 | Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, M... | Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C ... | Class III | JHP Pharmaceuticals, LLC |
| Jun 5, 2012 | Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi... | Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly... | Class II | Bristol-myers Squibb Company |
| May 21, 2012 | Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distri... | Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the ... | Class II | Kutol Products Co Inc |
| May 12, 2012 | HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject pr... | Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be... | Class I | Hospira Inc. |
| Apr 26, 2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. b... | Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t... | Class III | Bayer Healthcare, LLC |
| Apr 26, 2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a)... | Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t... | Class III | Bayer Healthcare, LLC |
| Apr 21, 2012 | X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distri... | Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hyd... | Class I | XRock Industries, LLC |
| Apr 17, 2012 | Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson... | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used... | Class III | Watson Laboratories Inc |
| Apr 17, 2012 | Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watso... | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used... | Class III | Watson Laboratories Inc |
| Apr 17, 2012 | Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Wats... | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used... | Class III | Watson Laboratories Inc |
| Apr 17, 2012 | Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartr... | Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL | Class I | Hospira Inc. |
| Apr 17, 2012 | Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Wats... | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used... | Class III | Watson Laboratories Inc |
| Apr 17, 2012 | Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle,... | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used... | Class III | Watson Laboratories 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.