Browse Drug Recalls
19 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 19 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 19 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 22, 2025 | Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactur... | Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds | Class II | Hikma Pharmaceuticals USA Inc. |
| Dec 19, 2024 | Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, ... | Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configur... | Class III | West-Ward Columbus Inc |
| Jul 8, 2024 | Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose b... | Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found ... | Class I | Hikma Pharmaceuticals USA Inc. |
| Mar 12, 2024 | Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul,... | The filter included in the carton has an expiration date that has expired prior to the expiration... | Class II | Hikma Pharmaceuticals USA Inc. |
| May 11, 2023 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 2... | Failed Impurities/Degradation Specifications: Out-of-specification results for total related comp... | Class II | Hikma Pharmaceuticals USA Inc. |
| Dec 16, 2022 | Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton... | Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-coun... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, M... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Aug 5, 2021 | Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx o... | Labeling: Not elsewhere classified: Mislabeling | Class III | Hikma Pharmaceuticals USA Inc. |
| Dec 7, 2020 | Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, ... | Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Inje... | Class II | Hikma Pharmaceuticals USA Inc. |
| Nov 3, 2020 | Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, ... | Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Inje... | Class II | Hikma Pharmaceuticals USA Inc. |
| Aug 14, 2020 | Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intra... | Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. | Class II | Hikma Pharmaceuticals USA Inc. |
| Jun 11, 2020 | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured b... | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap d... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jun 11, 2020 | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured b... | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap d... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jan 14, 2020 | methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only... | Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to rec... | Class III | Hikma Pharmaceuticals USA Inc. |
| Dec 17, 2019 | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose ... | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Class I | Hikma Pharmaceuticals USA Inc. |
| Dec 17, 2019 | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Class II | Hikma Pharmaceuticals USA 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.