Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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DateProductReasonClassFirm
Jun 21, 2013 I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcoh... Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... Class III Tween Brands Inc
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 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 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 (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 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 (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 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 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 & 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 17, 2013 ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distribu... Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 ... Class I Advance Pharmaceutical Inc
Jun 14, 2013 Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablet... Labeling: Missing Label; missing label on blister card Class III Boehringer Ingelheim Roxane Inc
Jun 13, 2013 Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingre... Failed Stability Specifications: Out of specification results for particle size were obtained at ... Class III Bayer HealthCare Pharmaceuticals Inc.
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
May 23, 2013 INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 m... Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is... Class II Indelicare LLC
May 3, 2013 Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Excl... Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredi... Class II Kareway Product Inc
May 1, 2013 CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed ... cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled in... Class II Medicis Pharmaceutical Corp
Apr 22, 2013 Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-0... Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was f... Class II Mylan Pharmaceuticals Inc.
Apr 22, 2013 Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufact... Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine ... Class II Legacy Pharmaceutical Packaging LLC
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
Apr 12, 2013 Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL... Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being reca... Class II OPMX, LLC
Apr 12, 2013 Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl... Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being reca... Class II OPMX, LLC
Apr 9, 2013 Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufa... Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label Class III Aurobindo Pharma USA Inc
Apr 9, 2013 (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: B... CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... Class II Total Resources Intl
Apr 1, 2013 Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... Class II Lloyd Inc. of Iowa
Apr 1, 2013 Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... Class II Lloyd Inc. of Iowa
Apr 1, 2013 Lloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... Class II Lloyd Inc. of Iowa
Apr 1, 2013 Lloyd Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... Class II Lloyd Inc. of Iowa
Apr 1, 2013 Lloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... Class II Lloyd Inc. of Iowa
Apr 1, 2013 Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... Class II Lloyd Inc. of Iowa
Apr 1, 2013 Lloyd Thyro-Tab 0.100 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... Class II Lloyd Inc. of Iowa
Apr 1, 2013 Lloyd Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... Class II Lloyd Inc. of Iowa
Apr 1, 2013 Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... Class II Lloyd Inc. of Iowa
Apr 1, 2013 Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... Class II Lloyd Inc. of Iowa
Mar 27, 2013 Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceu... Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 Class III Legacy Pharmaceutical Packaging LLC
Mar 21, 2013 Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 6... Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product'... Class II Precision Dose Inc.
Mar 19, 2013 Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By:... Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of ... Class III Dr. Reddy'S Laboratories
Mar 18, 2013 Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), R... Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration... Class II West-ward Pharmaceutical Corp.
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 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 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 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 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 4, 2013 SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP ... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 S... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators ... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC
Mar 4, 2013 FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net ... Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... Class II CareFusion 213, LLC

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.