Browse Drug Recalls
1,045 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,045 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 1,045 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 16, 2024 | Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine H... | Stability testing failures for one or two of the four active pharmaceutical ingredients among the... | Class II | Global Corporation |
| Feb 9, 2024 | Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured b... | Failed Stability Specifications: Out of specification for blend uniformity. | Class II | Micro Labs Limited |
| Feb 9, 2024 | HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 bli... | an out of specification result obtained during routine stability testing for Impurities. There i... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Jan 11, 2024 | Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 u... | Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper speci... | Class II | Par Sterile Products LLC |
| Dec 13, 2023 | Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-C... | CGMP Deviations: Stability data does not support expiry date. | Class II | Private Label Partners, Inc. |
| Dec 8, 2023 | Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufa... | Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylid... | Class III | Azurity Pharmaceuticals, Inc. |
| Nov 6, 2023 | VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manu... | Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicilliu... | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Nov 6, 2023 | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, ... | Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone relat... | Class III | Taro Pharmaceuticals Inc. |
| Oct 23, 2023 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30... | Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Aug 25, 2023 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1... | Class II | CareFusion 213, LLC |
| Aug 16, 2023 | Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Man... | Failed dissolution specifications: below specification results at stability 12-month | Class III | Esperion |
| Jul 18, 2023 | Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, ... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organ... | Class III | Ascend Laboratories, LLC |
| Jun 27, 2023 | Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufact... | Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term st... | Class III | Lupin Pharmaceuticals Inc. |
| Jun 26, 2023 | Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 687... | Failed Stability Specifications | Class II | Preferred Pharmaceuticals, Inc. |
| Jun 23, 2023 | PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only... | Failed Stability Specifications | Class III | Vivus, Inc. |
| Jun 23, 2023 | Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 m... | Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specific... | Class I | Lupin Pharmaceuticals Inc. |
| Jun 21, 2023 | Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr.... | Failed dissolution specification: Out of specification results observed in 24-month long term sta... | Class II | Dr Reddy's Laboratories Limited |
| May 9, 2023 | buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablet... | Failed Dissolution Specifications; during stability testing | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 26, 2023 | Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx O... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intraveno... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TEC... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous U... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manuf... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured b... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Dis... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, D... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Op... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn O... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distribute... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operatin... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL amp... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distrib... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, R... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Di... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distr... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manu... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL S... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, D... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distribute... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, 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.