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FDA Drug Recalls

1,709 recalls · Class III, newest first

Class III · Low risk Terminated Jun 19, 2014

Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of…

Reason Failed Dissolution Specification; at the 12 month time interval.

Mckesson Packaging Services D-1483-2014

Class III · Low risk Terminated Jun 17, 2014

Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg…

Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.

Teva Pharmaceuticals USA NDC 0555-9051-67 D-1439-2014

Class III · Low risk Terminated Jun 17, 2014

Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28…

Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.

Teva Pharmaceuticals USA NDC 0555-9050-58 D-1438-2014

Class III · Low risk Terminated Jun 17, 2014

Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28…

Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.

Teva Pharmaceuticals USA NDC 51285-114-58 D-1437-2014

Class III · Low risk Terminated Jun 17, 2014

Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva…

Reason Failed Impurities/Degradation Specifications: out of specification impurity test results.

Teva Pharmaceuticals USA NDC 0555-9043-58 D-1436-2014

Class III · Low risk Terminated Jun 6, 2014

DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories…

Reason Stability Data Does Not Support Expiry

Estee Lauder Inc D-1452-2014

Class III · Low risk Terminated Jun 5, 2014

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE…

Reason Labeling: Incorrect or Missing Package Insert

Valeant Pharmaceuticals North America LLC NDC 0024-5812-07 D-0053-2015

Class III · Low risk Terminated Jun 5, 2014

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE…

Reason Labeling: Incorrect or Missing Package Insert

Valeant Pharmaceuticals North America LLC NDC 0024-5811-07 D-0052-2015

Class III · Low risk Terminated Jun 5, 2014

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant…

Reason Labeling: Incorrect or Missing Package Insert

Valeant Pharmaceuticals North America LLC NDC 0024-5810-07 D-0051-2015

Class III · Low risk Terminated May 28, 2014

Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck…

Reason Failed Stability Specification; out of specification result for particle size distribution during stability testing

Novartis Pharmaceuticals Corp. NDC 0085-1401-01 D-1387-2014

Class III · Low risk Terminated May 21, 2014

Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7…

Reason Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.

Valeant Pharmaceuticals North America LLC NDC 0187-0140-90 D-0019-2015

Class III · Low risk Terminated May 21, 2014

Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant…

Reason Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset

Valeant Pharmaceuticals North America LLC NDC 0187-0146-01 D-0018-2015

Class III · Low risk Terminated May 14, 2014

Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA…

Reason Labeling: Missing Label; The label on the immediate bottle is missing.

Oasis Medical Inc D-1347-2014

Class III · Low risk Terminated Apr 25, 2014

PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and…

Reason Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution

Prestige Brands Holdings D-1353-2014

Class III · Low risk Terminated Apr 25, 2014

PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL)…

Reason Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution

Prestige Brands Holdings D-1352-2014

Class III · Low risk Terminated Apr 18, 2014

Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada…

Reason Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.

Apotex Corp. NDC 60505-3275-03 D-1609-2014

Class III · Low risk Terminated Apr 17, 2014

Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC…

Reason Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the…

Trigen Laboratories, Inc. NDC 13811-558-30 D-1544-2014

Class III · Low risk Terminated Apr 17, 2014

Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count…

Reason Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.

Wockhardt Usa Inc. NDC 64679-735-02 D-0304-2015

Class III · Low risk Terminated Apr 15, 2014

Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to…

Reason Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.

P&L Developments, LLC D-1298-2014

Class III · Low risk Terminated Apr 14, 2014

Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by…

Reason Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however…

Upsher Smith Laboratories, Inc. NDC 0245-0272-06 D-1255-2014

Class III · Low risk Terminated Apr 14, 2014

Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz…

Reason Subpotent Drug: Phenylephrine component is subpotent.

P&L Developments, LLC D-1254-2014

Class III · Low risk Terminated Apr 14, 2014

HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01

Reason Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an…

Fresenius Kabi USA LLC NDC 63323-469-01 D-0247-2015

Class III · Low risk Terminated Apr 11, 2014

Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant)…

Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.

Aaron Industries Inc D-1286-2014

Class III · Low risk Terminated Apr 9, 2014

Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India…

Reason Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Caraco Pharmaceutical Laboratories, Ltd. NDC 47335-344-83 D-1297-2014

Class III · Low risk Terminated Apr 9, 2014

Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83

Reason Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

Caraco Pharmaceutical Laboratories, Ltd. NDC 47335-343-83 D-1296-2014