Browse Drug Recalls
21 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 21 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 21 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 10, 2025 | Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile,... | Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. | Class II | Safecor Health, LLC |
| Feb 17, 2025 | Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg ... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 17, 2025 | Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solut... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 17, 2025 | Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Suppl... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 17, 2025 | Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrat... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 17, 2025 | Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral S... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Nov 11, 2024 | Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, ... | cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... | Class II | Safecor Health, LLC |
| Nov 11, 2024 | Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box,... | cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... | Class II | Safecor Health, LLC |
| Nov 11, 2024 | Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose ... | cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... | Class II | Safecor Health, LLC |
| Nov 11, 2024 | Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count ... | cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... | Class II | Safecor Health, LLC |
| Nov 11, 2024 | Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit... | cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... | Class II | Safecor Health, LLC |
| Oct 19, 2023 | Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dro... | CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements. | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor He... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Heal... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor He... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, ... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count ... | CGMP Deviations | Class II | Safecor Health, LLC |
| Aug 13, 2015 | Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf box... | Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece ... | Class II | Safecor Health, LLC |
| Jul 16, 2015 | Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg ... | Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml inst... | Class II | Safecor Health, LLC |
| Mar 2, 2015 | Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx ... | Defective Container: Confirmed customer complaints of leaking bottles. | Class II | Safecor Health, LLC |
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.