Browse Drug Recalls
2,029 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,029 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 2,029 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Mar 4, 2013 | SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodiu... | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... | Class II | CareFusion 213, LLC |
| Mar 4, 2013 | Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1... | Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile... | Class II | CareFusion 213, LLC |
| 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 27, 2013 | Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 5... | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... | Class III | Mutual Pharmaceutical Company, Inc. |
| Feb 27, 2013 | FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102... | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... | Class III | Mutual Pharmaceutical Company, Inc. |
| Feb 27, 2013 | Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mu... | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... | Class III | Mutual Pharmaceutical Company, Inc. |
| Feb 27, 2013 | 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, ... | Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injec... | Class II | Baxter Healthcare Corp. |
| Feb 19, 2013 | Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, No... | 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 |
| 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 | 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 | 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 4, 2013 | buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carto... | Failed Stability Specifications; out of specification results at the 9 month stability time point... | Class III | American Health Packaging |
| Feb 1, 2013 | CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, R... | Labeling: Missing label | Class III | Fresenius Kabi USA LLC (FK USA) |
| Feb 1, 2013 | TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescripti... | Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Fre... | Class III | Ferring Pharmaceuticals Inc |
| Jan 28, 2013 | Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp.... | Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled wit... | Class III | Stat Rx USA |
| Jan 23, 2013 | Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manuf... | Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect ... | Class III | Mission Pharmacal Co |
| Dec 28, 2012 | Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, M... | Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for ... | Class I | Advance Pharmaceutical Inc |
| Dec 21, 2012 | 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 m... | Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeli... | Class II | Lee Pharmaceuticals, Inc |
| Dec 10, 2012 | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity... | Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded ... | Class III | Upsher Smith Laboratories, Inc. |
| Dec 7, 2012 | Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifen... | Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from t... | Class III | Bayer Healthcare, LLC |
| Dec 4, 2012 | Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per b... | Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contain... | Class II | Abbott Laboratories |
| Nov 30, 2012 | Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, M... | Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Regist... | Class III | West-ward Pharmaceutical Corp. |
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.