Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Drug Recalls

188 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 188 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 188 FDA drug recalls.

Clear
DateProductReasonClassFirm
Mar 28, 2019 Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx on... Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was ob... Class III Akorn, Inc.
Feb 22, 2019 Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manu... Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individ... Class II Akorn, Inc.
Dec 20, 2018 COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol ... Failed Stability Specifications: out of specification results for opalescence at 7 month stabilit... Class III Akorn Inc
Oct 29, 2018 Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 ple... Failed Impurities/Degradation Specifications; out of specification results observed for other ind... Class III Akorn, Inc.
Oct 8, 2018 Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Onl... Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. Class II Akorn, Inc.
Aug 24, 2018 Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For... Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified ... Class II Akorn, Inc.
Aug 8, 2018 Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle... Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-... Class III Akorn, Inc.
Aug 1, 2018 Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by... Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impuri... Class II Akorn, Inc.
Jun 22, 2018 Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by ... CGMP Deviations Class II Akorn, Inc.
Mar 29, 2018 Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-72... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 9, 2018 Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by:... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class III Akorn, Inc.
Feb 21, 2018 Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Onl... Failed Stability Specification: OOS low viscosity results discovered during retain testing. Class III Akorn, Inc.
Apr 20, 2017 IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit con... Product is being recalled due to low pH value. Class III Akorn, Inc.
Mar 17, 2017 LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL b... Lack of assurance of sterility: product was found to be empty, under-filled, or leaking. Class II Akorn, Inc.
Oct 21, 2016 Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akor... Subpotent Drug: concentration of product is less than labeled amount. Class II Akorn Inc
Jul 27, 2016 Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, ... Failed impurities/degradation specifications: product was out of specification for unknown impuri... Class III Akorn, Inc.
May 17, 2016 Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL b... Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability Class II Akorn, Inc.
Apr 7, 2016 Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 ... Presence of Particulate Matter Class II Akorn, Inc.
Mar 23, 2016 ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (47... Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ... Class II Akorn, Inc.
Mar 23, 2016 PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. ... Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ... Class II Akorn, Inc.
Mar 23, 2016 Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PE... Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ... Class II Akorn, Inc.
Aug 21, 2015 Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone ... Defective Container: Product missing safety seal around the neck of the bottle. The product labe... Class III Akorn, Inc.
Aug 20, 2015 RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lak... Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known im... Class III Akorn, Inc.
Apr 20, 2015 IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02,... Subpotent Drug: Low out-of-specification potency result of the drug product. Class III Akorn, Inc.
Apr 7, 2015 Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) b... Failed Impurities/Degradation Specifications Class II Akorn, Inc.
Apr 7, 2015 Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) b... Failed Impurities/Degradation Specifications Class II Akorn, Inc.
Mar 24, 2015 Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL... Failed Content Uniformity Specifications: The product may not meet finished product release speci... Class III Nomax Inc
Mar 24, 2015 Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Flu... Failed Content Uniformity Specifications: The product may not meet finished product release speci... Class III Nomax Inc
Mar 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL,... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, Inc.
Mar 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL,... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, Inc.
Mar 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, Inc.
Feb 27, 2015 Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bo... Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. Class II Akorn, Inc.
Jan 28, 2015 Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, ... Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed US... Class II Akorn, Inc.
Dec 9, 2014 Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size:... Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 ... Class III Akorn, Inc.
Aug 5, 2014 Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass... Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl im... Class III Akorn, Inc.
Jun 18, 2012 Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only... Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "oi... Class III Stat Rx USA

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.