Browse Drug Recalls
1,710 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,710 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 1,710 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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 | 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 |
| Apr 16, 2012 | Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, ... | Short Fill: The product is being recalled due to a potential underfill of the affected vials. | Class III | Bracco Diagnostics Inc |
| Apr 5, 2012 | Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g t... | Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesi... | Class III | Hospira, Inc. |
| Mar 29, 2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets... | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... | Class III | McKesson Packaging Services |
| Mar 29, 2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets... | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... | Class III | McKesson Packaging Services |
| Mar 20, 2012 | DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distribut... | Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subp... | Class III | Quadrant Chemical Corporation |
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.