Browse Drug Recalls
52 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 52 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 52 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 24, 2016 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pac... | Defective Delivery System; reports of damaged product that may alter the predicted release of sco... | Class II | Sandoz Inc |
| Sep 11, 2013 | Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consume... | Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets. | Class III | Physicians Total Care, Inc. |
| Sep 3, 2013 | Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufac... | Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken t... | 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 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 | 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 |
| Jun 18, 2013 | Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, ... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochlori... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and ph... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextro... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HB... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydr... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hy... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan ... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 m... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diph... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | Theraflu Severe Cold & Cough powder packets containing Daytime formula (aceta... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 18, 2013 | NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydr... | Presence of Foreign Substance: The products are being recalled because they may contain foreign s... | Class II | Novartis Consumer Health |
| Jun 6, 2013 | Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caf... | Defective container: products are packaged in pouches which may not have been fully sealed | Class II | Novartis Consumer Health |
| Jun 6, 2013 | No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Di... | Defective container: products are packaged in pouches which may not have been fully sealed | Class II | Novartis Consumer Health |
| Jun 6, 2013 | Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen... | Defective container: products are packaged in pouches which may not have been fully sealed | Class II | Novartis Consumer Health |
| Jun 6, 2013 | Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine ... | Defective container: products are packaged in pouches which may not have been fully sealed | Class II | Novartis Consumer Health |
| May 15, 2013 | Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorphen... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Class III | Novartis Consumer Health |
| May 15, 2013 | Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlor... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Class III | Novartis Consumer Health |
| May 15, 2013 | Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorph... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Class III | Novartis Consumer Health |
| May 15, 2013 | Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextrometho... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing | Class III | Novartis Consumer Health |
| May 15, 2013 | Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 cap... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing | Class III | Novartis Consumer Health |
| May 15, 2013 | Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorph... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Class III | Novartis Consumer Health |
| May 15, 2013 | Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen... | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Class III | Novartis Consumer Health |
| Apr 19, 2013 | Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tub... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
| Mar 7, 2013 | Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-... | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Mar 7, 2013 | 4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hy... | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Mar 7, 2013 | 4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydroc... | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Mar 7, 2013 | Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. t... | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Mar 7, 2013 | 4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, ... | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Mar 2, 2013 | Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa ... | Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because... | Class III | Physicians Total Care, Inc. |
| Feb 19, 2013 | Target Up & Up, athlete's foot cream, full prescription strength, terbinafine... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
| Feb 19, 2013 | Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX onl... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
| Feb 19, 2013 | Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) T... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
| Feb 19, 2013 | Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifun... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... | Class III | Novartis Consumer Health |
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.