Unrated Drug recall · FDA · Published May 2, 2023

Apollo Care Fentanyl 500 mcg Injection Recall: Lack of Sterility Assurance

Apollo Care recalls Fentanyl 500 mcg injections due to lack of sterility assurance. This risks infections from improper sterilization during medical use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0646-2023Drug Apollo Care ›

Recall notice

Lack of Assurance of Sterility

Take action

Contact the company

Recalling firmApollo Care, LLC3801 Mojave Ct Ste 101 · Columbia, MO 65202-4042

✎ GovInfoNow plain-language explainer

Apollo Care is recalling Fentanyl 500 mcg injections that may not be sterile, posing infection risks during medical procedures. Patients should not use these products without contacting their healthcare provider. Read more at govinfonow.com/recall/33502-apollo-care-fentanyl-500-mcg-injection-recall-lack-of-sterility.

Source Summary by GovInfoNow · govinfonow.com/recall/33502-apollo-care-fentanyl-500-mcg-injection-recall-lack-of-sterility · Updated September 23, 2026 · FDA enforcement record: FDA #D-0646-2023

Cite this page

“Apollo Care Fentanyl 500 mcg Injection Recall: Lack of Sterility Assurance.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33502-apollo-care-fentanyl-500-mcg-injection-recall-lack-of-sterility. Based on FDA recall #D-0646-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0646-2023%22&limit=1).

The FDA announced on May 2, 2023, that Apollo Care, LLC is recalling FentaNYL and Ropivacaine HCL injection bags due to a lack of assurance of sterility. Owners should contact the company for details on the remedy.

How to tell if you have it

Brand: Apollo Care
Product: FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only
NDC: 71170-950-25
Lot codes: AC-016644 (Exp. Date 05/08/2023), AC-016659 (Exp. Date 09/26/2023)
Quantity: 308 bags
Distribution: Missouri only

The hazard

The recall is due to a lack of assurance of sterility in the injection bags. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Apollo Care, LLC has issued two other recalls since April 15, 2025, including a July 29, 2026, recall for particulate matter in Semaglutide vials and an April 15, 2025, recall for lack of sterility risk in Fentanyl injections. Other recent recalls of similar products include Huons Lidocaine HCl Injection Recall (April 2, 2026), New Life Pharma Semaglutide Injections Recall (Feb. 26, 2026), and Huons Co Lidocaine HCl Injection Recall (April 2, 2026).

How to tell if you have this one

Check for NDC 71170-950-25 with lot number AC-016644 (expiring May 2023) or AC-016659 (expiring September 2023). These are prescription-only injections sold by Apollo Care.

Brand
Apollo Care
Category
Drug

FDA recall event · 16 products

All 16 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Missouri only

Recall number	Product, codes & lots	Quantity
D-0632-2023	PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10; Lot #: AC-016606, Exp. Date 05/06/2023; AC-016636, Exp. Date 07/09/2023; AC-016643, Exp. Date 07/31/2023	2265 syringes
D-0633-2023	Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05; Lot #: AC-016607, Exp. Date 05/09/2023	90 syringes
D-0634-2023	FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25; Lot #: AC-016624, Exp. Date 06/10/2023	790 syringes
D-0635-2023	Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05; Lot #: AC-016627, Exp. Date 06/17/2023; AC-016635, Exp. Date 07/08/2023; AC-016662, Exp. Date 09/30/2023	2040 syringes
D-0636-2023	VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50; Lot#: AC-016629, Exp. Date 05/13/2023; AC-016646, Exp. Date 06/24/2023	2040 bags
D-0637-2023	Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25; Lot#: AC-016631, Exp. Date 05/29/2023; AC-016655, Exp. Date 08/07/2023	1617 bags
D-0638-2023	VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25; Lot #: AC-016647, Exp. Date 06/28/2023	1113 bags
D-0639-2023	VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25; Lot #: AC-016647, Exp. Date 06/28/2023	1113 bags
D-0640-2023	VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25; Lot #: AC-016641, Exp. Date 06/03/2023; AC-016653 Exp. Date 07/26/2023	1622 bags
D-0641-2023	VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50; Lot #: AC-016648, Exp. Date 07/01/2023	240 bags
D-0642-2023	VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50; Lot #: AC-016638, Exp. Date 05/27/2023	413 bags
D-0643-2023	VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50; Lot #: AC-016649, Exp. Date 07/01/2023	54 bags
D-0644-2023	Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25; Lot #: AC-016640, Exp. Date 06/16/2023; AC-016670, Exp. Date 08/29/2023	682 bags
D-0645-2023	VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25; Lot #: AC-016632, Exp. Date 05/24/2023	491 bags
D-0646-2023	FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25; Lot #: AC-016644, Exp. Date 05/08/2023; AC-016659, Exp. Date 09/26/2023	308 bags
D-0647-2023	VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25; Lot #: AC-016633, Exp. Date 05/24/2023; AC-016651, Exp. Date 07/22/2023	646 bags

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the lot number and expiration date on the packaging to confirm if the product is recalled.

Where it went and when

Where it was distributed

Distributed in Missouri.

FDA distribution: “Missouri only” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Missouri.

Recall timeline

FDA published this recall 22 days after the firm started it.

May 2, 2023Firm started the recall
May 18, 2023FDA classified it Class II
May 24, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/33502-apollo-care-fentanyl-500-mcg-injection-recall-lack-of-sterility">Apollo Care Fentanyl 500 mcg Injection Recall: Lack of Sterility Assurance (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0646-2023 (May 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0646-2023 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.