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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
Apr 24, 2018 Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laborat... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 23, 2018 Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 23, 2018 Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx On... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 23, 2018 Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottl... Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was foun... Class II Dr. Reddy's Laboratories, Inc.
Apr 23, 2018 Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx on... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 20, 2018 Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-co... Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg containe... Class II Exela Pharma Sciences LLC
Apr 19, 2018 Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-co... Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimeth... Class II Sun Pharmaceutical Industries, Inc.
Apr 17, 2018 Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-... Failed Dissolution Specification: Low dissolution outside of specifications Class III Rhodes Pharmaceuticals, L.P.
Apr 16, 2018 Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count bl... Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxy... Class I Epic Products, LLC
Apr 13, 2018 Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx... Subpotent Drug Class II Lyne Laboratories, Inc.
Apr 13, 2018 Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufac... Subpotent Drug Class II Lyne Laboratories, Inc.
Apr 13, 2018 OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box ... Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS... Class III Septodont Inc.
Apr 13, 2018 Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx... Subpotent Drug Class II Lyne Laboratories, Inc.
Apr 13, 2018 Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed... Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement o... Class III Boiron Inc.
Apr 12, 2018 Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadal... Class I AMA Wholesale
Apr 11, 2018 NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Pre... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. ... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 10, 2018 Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 ... cGMP deviations Class III Pharmedium Services, LLC
Apr 10, 2018 Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 co... Failed Stability Specifications Class II Pharmalucence, Inc.
Apr 10, 2018 Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 Presence of Foreign Tablets/Capsules Class III Aidarex Pharmaceuticals LLC
Apr 9, 2018 Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... Defective Delivery System: Out of specification for adhesive transfer. Class II Noven Pharmaceuticals, Inc.
Apr 9, 2018 Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manuf... Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. Class III LEADIANT BIOSCIENCES, INC
Apr 6, 2018 Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bott... Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisino... Class III Sandoz Incorporated
Apr 5, 2018 ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste ... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr.,... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., ... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C B... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., ... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bio... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., S... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C ... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 5, 2018 PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, LLC.
Apr 3, 2018 Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Ki... Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Otezla 30 mg tablet NDC 59572-0631-06 30 days supply; Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Altera Handset NDC 83490-0678-05 56 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-020... Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply. Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, 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.