Browse Drug Recalls

1,720 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,720 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 1,720 FDA drug recalls, Class III.

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DateProductReasonClassFirm
Oct 15, 2012 AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 m... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
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 20, 2012 Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manuf... Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacycl... Class III Sandoz Incorporated
Sep 12, 2012 Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, R... Impurities/Degradation Products: An out of specification result for a known impurity of the produ... Class III Sandoz Incorporated
Sep 12, 2012 Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx... Impurities/Degradation Products: An out of specification result for a known impurity of the produ... Class III Sandoz Incorporated
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 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 17, 2012 Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by... Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide... Class III Axcentria Pharmaceuticals LLC
Aug 15, 2012 Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For ... Subpotent; fluocinolone acetonide. Class III Galderma Laboratories, L.P.
Aug 14, 2012 Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phen... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic LLC
Aug 14, 2012 Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials ... Presence of Particulate Matter; potential for charcoal particulates Class III Bracco Diagnostic Inc
Aug 14, 2012 Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic LLC
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 27, 2012 Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 f... Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkh... Class III Natural Essentials 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 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 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 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 6, 2012 HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bot... Impurities/Degradation Products: High Out of Specification results for a known impurity resulted ... Class III Vintage Pharmaceuticals LLC DBA Qualitest Pharm...
Jul 6, 2012 HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg... Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month roo... Class III Vintage Pharmaceuticals LLC DBA Qualitest Pharm...
Jul 2, 2012 Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) ... Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin AP... Class III Hospira Inc.
Jul 2, 2012 Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count b... Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexi... Class III ASTRA ZENECA Lp
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 28, 2012 Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceutic... Impurities/Degradation Products: Out of specification results for Related Compound during routine... Class III Mylan Pharmaceuticals Inc.
Jun 21, 2012 Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, ... CGMP Deviations: Shipment of product not approved for release. Class III 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 7, 2012 Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only.... Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di... Class III Fougera Pharmaceuticals, Inc.
Jun 5, 2012 Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen)... Impurities/Degradation Products: High Out-of-specification results were obtained for both known a... Class III Watson Laboratories Inc
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
May 31, 2012 Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, ... Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin... Class III Bayer HealthCare Pharmaceuticals Inc.
May 25, 2012 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 ... Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone ... Class III Mallinckrodt Inc.
May 17, 2012 Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg,... Defective Container; damaged blister units Class III Mcneil Consumer Healthcare, Div Of Mcneil-ppc, ...
May 8, 2012 Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber d... Impurities/Degradation Products: The product was found to contain a slightly out of specification... Class III Morton Salt Co.
May 8, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl... Subpotent; fluocinolone acetonide Class III Hill Dermaceuticals, Inc.
May 8, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28m... Subpotent; fluocinolone acetonide Class III Hill Dermaceuticals, Inc.
May 7, 2012 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... Subpotent Drug: Salicylic acid is subpotent. Class III Guthy-Renker LLC
May 7, 2012 Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count t... Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablet... Class III Endo Pharmaceuticals, Inc.
May 7, 2012 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... Subpotent Drug: Salicylic acid is subpotent. Class III Guthy-Renker LLC
May 7, 2012 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... Subpotent Drug: Salicylic acid is subpotent. Class III Guthy-Renker LLC
May 7, 2012 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... Subpotent Drug: Salicylic acid is subpotent. Class III Guthy-Renker LLC
May 7, 2012 Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... Subpotent Drug: Salicylic acid is subpotent. Class III Guthy-Renker LLC
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 24, 2012 CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA... Impurities/Degradation Products: This lot of product will not meet the impurity specification ove... Class III Teva Pharmaceuticals USA, Inc.
Apr 23, 2012 Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each... Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that s... Class III Teva Pharmaceuticals USA, 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.