Browse Drug Recalls
534 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 534 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 534 FDA drug recalls in 2012.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 21, 2012 | Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector S... | Presence of Particulate Matter; fibers identified as cellulose and polyvinyl | Class I | Bracco Diagnostic Inc |
| Nov 21, 2012 | Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66... | Presence of Particulate Matter; fibers identified as cellulose and polyvinyl | Class I | Bracco Diagnostic 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 | Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmac... | Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and descripti... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Nov 20, 2012 | Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules... | Failed Dissolution Test Requirements | Class II | Upsher Smith Laboratories, 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 |
| Nov 15, 2012 | Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusio... | Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observ... | Class II | Hospira Inc. |
| Nov 15, 2012 | Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles... | Subpotent; 15 month stability (by mfr) | Class II | Physicians Total Care, Inc. |
| Nov 9, 2012 | Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets... | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg ma... | Class II | Ranbaxy Inc. |
| Nov 9, 2012 | Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufact... | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg ma... | Class II | Ranbaxy Inc. |
| Nov 9, 2012 | Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufact... | Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg ma... | Class II | Ranbaxy Inc. |
| Nov 8, 2012 | Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Steri... | Crystallization: Product is being recalled due to visible particulates identified during a retain... | Class I | Hospira Inc. |
| Nov 8, 2012 | Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Steri... | Crystallization: Product is being recalled due to visible particulates identified during a retain... | Class I | Hospira Inc. |
| Nov 8, 2012 | Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor ... | Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the wa... | Class II | Procter & Gamble Co |
| Nov 6, 2012 | VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vi... | Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity... | Class II | Alkermes, Inc. |
| Nov 5, 2012 | traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Man... | Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Trama... | Class II | Caraco Pharmaceutical Laboratories, Ltd. |
| Nov 5, 2012 | Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Di... | Defective container; damaged bottles could allow moisture to get into the bottle and thus may imp... | Class II | Boehringer Ingelheim Roxane Inc |
| Nov 2, 2012 | ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, ... | CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not se... | Class II | Bristol Myers Squibb Manufacturing Company |
| Oct 31, 2012 | All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A compl... | Lack of assurance of sterility | Class II | Ameridose LLC |
| Oct 31, 2012 | All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A c... | GMP deficiencies | Class II | Ameridose LLC |
| Oct 29, 2012 | Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by ... | Subpotent; 15 month stability | Class II | Alara Pharmaceutical Co |
| Oct 25, 2012 | Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., ... | Presence of Particulates; may contain glass particles | Class II | Hospira Inc. |
| 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 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 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 22, 2012 | Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bot... | Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the... | Class I | Zi Xiu Tang Success, LLC |
| Oct 22, 2012 | Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi... | Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the... | Class I | Zi Xiu Tang Success, LLC |
| Oct 22, 2012 | HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MA... | Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of ... | Class II | Hospira Inc. |
| Oct 19, 2012 | Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, ... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| Oct 19, 2012 | Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg,... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| Oct 19, 2012 | Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, in... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| Oct 19, 2012 | Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, ... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| Oct 19, 2012 | Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg,... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| 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 |
| 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 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 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 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 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 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 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 11, 2012 | Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured f... | Tablet Separation: Possibility of cracked or split coating on the tablets. | Class II | Vintage Pharmaceuticals LLC DBA Qualitest Pharm... |
| Oct 10, 2012 | QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packa... | Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months ... | Class II | American Health Packaging |
| Oct 8, 2012 | Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusio... | Impurities/Degradation Products: Potential for drug related impurities to exceed the specificatio... | Class II | GlaxoSmithKline, LLC. |
| Oct 6, 2012 | All Non Sterile Products manufactured by NECC (New England Compounding Center... | GMP Deviations | Class II | New England Compounding Center |
| Oct 6, 2012 | All Sterile Products manufactured by NECC (New England Compounding Center), F... | Lack of Assurance of Sterility | Class II | New England Compounding Center |
| Oct 5, 2012 | Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz... | Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final ... | Class II | Earthborn Products, Inc. |
| Oct 5, 2012 | Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers... | Non-Sterility: One confirmed customer report that product contained spore-like particulates, cons... | Class I | Hospira Inc. |
| Oct 4, 2012 | Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, ... | Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded i... | Class II | Hospira, 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.