Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 22, 2013 | Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blist... | Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debo... | Class III | Sandoz Incorporated |
| Jan 18, 2013 | Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorp... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Jan 18, 2013 | Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextro... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Jan 18, 2013 | Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextro... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Jan 18, 2013 | Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Jan 16, 2013 | Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use ... | Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. | Class III | Actelion Pharmaceuticals U.S., Inc. |
| Jan 11, 2013 | PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Sus... | Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. | Class III | AstraZeneca LP |
| Jan 11, 2013 | PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampul... | Does Not Meet Monograph: Budesonide may be slightly above or below the specification range. | Class III | AstraZeneca LP |
| Jan 7, 2013 | Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactu... | Subpotent Drug | Class III | West-ward Pharmaceutical Corp. |
| Jan 4, 2013 | buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bot... | Failed Dissolution Specifications; 8-hours for the 18-month stability testing point. | Class III | Actavis Pharmaceuticals |
| Dec 27, 2012 | Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only... | Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which ... | Class III | Ranbaxy Inc. |
| Dec 27, 2012 | Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tub... | Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which ... | Class III | Ranbaxy Inc. |
| Dec 21, 2012 | Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactu... | Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles | Class III | Warner Chilcott Company LLC |
| Dec 21, 2012 | Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactur... | Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles | Class III | Warner Chilcott Company LLC |
| Dec 18, 2012 | Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting... | Defective Container: Product lacks tamper evident breakaway band on cap. | Class III | Belmora LLC |
| Dec 13, 2012 | Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen)... | Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities. | Class III | Watson Laboratories Inc |
| Dec 12, 2012 | Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringe... | Impurities/Degradation Products: Out of Specification results found for impurity B, identified as... | Class III | Boehringer Ingelheim Roxane 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 | Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC,... | Superpotent (Single Ingredient Drug): salicylic acid | Class III | Johnson & Johnson |
| 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. |
| Nov 26, 2012 | TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packa... | Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the di... | Class III | Pfizer Inc. |
| Nov 21, 2012 | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx on... | Subpotent; 22 month stability timepoint | Class III | Hill Dermaceuticals, Inc. |
| Nov 21, 2012 | Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx o... | Subpotent; 12 month stability timepoint | Class III | Hill Dermaceuticals, Inc. |
| Nov 19, 2012 | EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump ... | Defective Container: Pump head detaching from the canister unit upon removal of the overcap. | Class III | Ascend Therapeutics Inc |
| Oct 24, 2012 | Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation A... | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle si... | Class III | GlaxoSmithKline, LLC. |
| Oct 24, 2012 | Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 m... | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle si... | Class III | GlaxoSmithKline, LLC. |
| Oct 23, 2012 | ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxida... | Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stabl... | Class III | Estee Lauder Inc |
| Oct 15, 2012 | AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads pe... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic aci... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v)... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g)... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 m... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 ... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid... | Class III | Valeant Pharmaceuticals |
| Sep 28, 2012 | Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%)... | CGMP Deviations: The products were manufactured with raw material which contain unknown particles... | Class III | ITW Dymon |
| Sep 27, 2012 | CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-co... | Short Fill: some bottles contained less than 120-count per labeled claim. | Class III | Genentech, Inc. |
| Sep 20, 2012 | Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manuf... | Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacycl... | Class III | Sandoz Incorporated |
| Sep 12, 2012 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, R... | Impurities/Degradation Products: An out of specification result for a known impurity of the produ... | Class III | Sandoz Incorporated |
| Sep 12, 2012 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx... | Impurities/Degradation Products: An out of specification result for a known impurity of the produ... | Class III | Sandoz Incorporated |
| Sep 4, 2012 | Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, ... | Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. | Class III | Apace KY LLC |
| 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 |
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.