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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.