Browse Drug Recalls
18,008 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18,008 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 18,008 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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. |
| 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 | 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 | Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 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 | 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 | Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon ... | Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat render... | Class II | Apotex Corp. |
| 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 | 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 | 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 | XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 m... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power C... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, 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 | 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 | 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 | 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 | Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile,... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 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 | Tropicamide Ophthalmic Solution, USP 0.1%, 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 | Calcitriol Injection 1 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 | Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramu... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distrib... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distribut... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufa... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by B... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, Inc |
| Apr 26, 2023 | Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc.... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes,... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose ... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, Inc |
| Apr 26, 2023 | Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Ak... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottl... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, Fo... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, F... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Ak... | 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.