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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.