Lower riskDrug recall · FDA · Published May 9, 2023
SSM Health Care Recalls Hydrocodone Syringes Due to Quality Control Issues
SSM Health Care recalls specific hydrocodone syringes manufactured with CGMP deviations. These products may not meet required quality standards. Consumers should check product details and contact the manufacturer for guidance.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Take action
Contact the company
📍Recalling firmSSM Health Care St. Louis DBA SSM St. Clare Health Center1015 Bowles Ave · Fenton, MO 63026-2394
“SSM Health Care Recalls Hydrocodone Syringes Due to Quality Control Issues.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33494-ssm-health-care-recalls-hydrocodone-syringes-due-to-quality-control. Based on FDA recall #D-0776-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0776-2023%22&limit=1).
The Food and Drug Administration announced on May 9, 2023, that SSM Health Care St. Louis DBA SSM St. Clare Health Center is recalling HYDROmorphone HCl 10 mg syringes due to current good manufacturing practice deviations. The agency stated the manufacturer discontinued its quality program, which could affect product identity, strength, quality, and purity.
How to tell if you have it
Brand: SSM Health Care
Product: HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only
The recall addresses CGMP deviations resulting from the discontinuation of the manufacturer's quality program. This action means the product may not meet the identity, strength, quality, and purity characteristics purported or represented to possess.
Context
GovInfoNow's records show SSM St. Clare Health Center has three other recalls on record since August 10, 2017. Other recent recalls of similar products include Fentanyl Citrate Vials (February 29, 2024), Potassium Chloride Solution (September 22, 2021), and Morphine 50 mg in 0.9% Sodium Chloride (August 10, 2017). Other recent recalls of similar products include Eye Drops (March 3, 2026), Fentanyl Citrate Injectable Solution (April 1, 2026), and Sildenafil (August 3, 2026).
How to tell if you have this one
Check for the product name 'HYDROmorphone HCl 10 mg in 0.9% Sodium Chloride, 50 mL syringe (0.2 mg/mL)' and the lot numbers listed in the recall notice. The product is prescription-only and sold through SSM Health Care.
Brand
SSM Health Care
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product by checking the lot number and expiration date on the syringe label.
Where it went and when
Where it was distributed
Distributed in Missouri.
Listed by the agency
Not listed
FDA distribution: “Product was distributed in Missouri.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Missouri.
Recall timeline
FDA published this recall 29 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0776-2023 (May 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0776-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.