Safecor Health, LLC

Complete recall history across all FDA and CPSC categories — 22 total recalls

Safecor Health, LLC appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Food Recalls (1)

FDA food safety enforcement actions by Safecor Health, LLC

Date Product Reason Class
Sep 12, 2016 Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-0108-01 Distribute... Box labeled Thiamine Hydrochloride instead of Thiamine Mononitrate Class III

Drug Recalls (21)

FDA drug safety enforcement actions by Safecor Health, LLC

Date Product Reason Class
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 produ... Class II
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 repackage... Class II
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 repackage... Class II
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 repackage... Class II
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 repackage... Class II
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 repackage... Class II
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 sep... Class II
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 sep... Class II
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 sep... Class II
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 sep... Class II
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 sep... Class II
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
Jul 7, 2016 Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor He... CGMP Deviations Class II
Jul 7, 2016 Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health... CGMP Deviations Class II
Jul 7, 2016 Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Heal... CGMP Deviations Class II
Jul 7, 2016 Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor He... CGMP Deviations Class II
Jul 7, 2016 Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, ... CGMP Deviations Class II
Jul 7, 2016 Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count ... CGMP Deviations Class II
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 cont... Class II
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 prod... Class II
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

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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