Browse Drug Recalls

1,720 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,720 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 1,720 FDA drug recalls, Class III.

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DateProductReasonClassFirm
Jan 28, 2014 Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets ... Failed Impurity/degradation Specification Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 27, 2014 Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstit... Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit... Class III Lupin Pharmaceuticals Inc.
Jan 27, 2014 Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstitute... Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit... Class III Lupin Pharmaceuticals Inc.
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister... This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... Class III Merck & Co Inc
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister... This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... Class III Merck & Co Inc
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister... This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... Class III Merck & Co Inc
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister... Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which c... Class III Merck & Co Inc
Jan 2, 2014 Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.... Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of spec... Class III Pfizer Inc.
Dec 16, 2013 Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) ... Failed impurities/degradation specifications; out of specification for the known impurity 4-chlor... Class III Qualitest Pharmaceuticals
Dec 16, 2013 VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx On... Failed Stability Testing: This product is below specification for preservative content. Class III Bracco Diagnostics Inc
Dec 6, 2013 FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Do... Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point Class III Fresenius Kabi USA, LLC
Dec 4, 2013 Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 mete... Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aer... Class III Teva Pharmaceuticals USA
Nov 18, 2013 KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division o... Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. Class III Fougera Pharmaceuticals Inc.
Nov 15, 2013 BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 co... Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. Class III Actavis Inc
Nov 14, 2013 Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, L... Failed Stability Specifications: this product is below specification for preservative content. Class III Teva Pharmaceuticals USA, Inc.
Nov 13, 2013 Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, ... Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... Class III Forest Pharmaceuticals Inc
Nov 13, 2013 Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, pa... Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... Class III Forest Pharmaceuticals Inc
Nov 13, 2013 Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) ext... Failed Dissolution Specifications: Three lots of product being recalled having failed stability d... Class III Forest Pharmaceuticals Inc
Nov 8, 2013 PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple ... Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinica... Class III Fresenius Kabi USA, LLC
Nov 6, 2013 Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bot... Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content duri... Class III Sandoz Inc
Nov 4, 2013 Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, ... Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr... Class III Greenstone Llc
Nov 4, 2013 Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, R... Failed Dissolution Specification; 8 hr stability timepoint Class III Pfizer Inc.
Oct 28, 2013 Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx onl... Failed Stability Specification; product viscosity and or pH are below specification. Class III Hi-Tech Pharmacal Co., Inc.
Oct 16, 2013 Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharm... Subpotent. drug Class III Taro Pharmaceuticals U.S.A., Inc.
Oct 2, 2013 Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blist... Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mE... Class III Cardinal Health
Sep 30, 2013 G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b... Failed Content Uniformity Specifications; at the 18 month time point. Class III G & W Laboratories Inc
Sep 25, 2013 Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bot... Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate T... Class III Sandoz Incorporated
Sep 23, 2013 Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for S... Subpotent Class III Tolmar, Inc.
Sep 20, 2013 Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt... Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an in... Class III Valeant Pharmaceuticals North Am
Sep 19, 2013 ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Man... Discoloration; due to prolonged heat exposure. Class III Ferring Pharmaceuticals Inc
Sep 16, 2013 Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, pac... Failed Dissolution Specification:12 hour time point at 18 months of product shelf life. Class III Osmotica Pharmaceutical Corp
Sep 11, 2013 Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consume... Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets. Class III Physicians Total Care, Inc.
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-1... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The pro... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The prod... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-5... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 8, 2013 Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Sep 8, 2013 Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Sep 4, 2013 GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-... Subpotent; phenylephrine HCl Class III Hi-Tech Pharmacal Co., Inc.
Sep 3, 2013 Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufac... Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken t... Class III Novartis Consumer Health
Aug 30, 2013 SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per... Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic ... Class III Boehringer Ingelheim Roxane Inc
Aug 30, 2013 Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 ... Defective Container: Defective bottles may not have tamper evident seals properly seated, and th... Class III Watson Laboratories Inc
Aug 21, 2013 buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2... Class III Actavis South Atlantic LLC
Aug 7, 2013 Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 m... Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorg... Class III Sandoz Incorporated
Aug 6, 2013 Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and algi... Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... Class III Novartis Consumer Health
Aug 6, 2013 Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicon... Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... Class III Novartis Consumer Health
Aug 6, 2013 Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, W... Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... Class III Novartis Consumer Health
Aug 6, 2013 Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg... Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... Class III Novartis Consumer Health

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.