Browse Drug Recalls
24 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 24 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 24 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufacture... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, Inc. |
| Apr 26, 2023 | Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufac... | 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, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL... | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Class II | Akorn, 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. |
| Mar 25, 2020 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per car... | Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.... | Class III | Akorn Inc |
| Dec 16, 2019 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx o... | Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of th... | Class II | Akorn Inc |
| Aug 6, 2019 | Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, Fo... | Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) an... | Class III | Akorn, Inc. |
| Aug 6, 2019 | Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 1... | Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-as... | Class III | Akorn, Inc. |
| Jun 7, 2019 | Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsu... | Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primar... | Class III | Akorn Inc |
| Apr 23, 2019 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per car... | Failed impurities/degradation specification: Out of Specification result for total impurity at 4.... | Class III | Akorn Inc |
| Mar 12, 2019 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, ... | Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testi... | Class II | Akorn Inc |
| Feb 4, 2019 | Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl... | Failed Stability Specification: out of specification results for Sodium Perborate | Class II | Akorn Inc |
| Jan 25, 2019 | Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) an... | Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month ... | Class III | 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 |
| Dec 15, 2017 | Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bo... | CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufact... | Class III | Akorn Inc |
| Jul 12, 2017 | Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlor... | Crystallization with subpotent out of specification assay results for chlorhexidine. | Class III | Akorn Inc |
| Jul 12, 2017 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose ... | Crystallization with subpotent out of specification assay results for chlorhexidine. | Class III | Akorn Inc |
| Jul 12, 2017 | Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlor... | Crystallization with subpotent out of specification assay results for chlorhexidine. | Class III | Akorn Inc |
| Mar 13, 2017 | Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 m... | Failed Dissolution Specifications | Class II | Akorn Inc |
| Nov 14, 2016 | Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60... | Failed Stability Specifications; out-of specification value for homogeneity / phase separation. | 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 |
| 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. |
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.