Skip to content
Get alerts
GovInfoNow
Lower risk Drug recall · FDA · Published December 11, 2018

Enovachem Dyural-40 Injection Kit Recall: Latex in Stopper

Enovachem recalls Dyural-40 Injection Kits due to latex in stoppers. These kits contain sodium chloride 0.9% and were distributed with specific lot numbers. Affected users should contact the manufacturer for details.

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

🇺🇸 FDA recall #D-0353-2019DrugEnovachem ›
Take action

Contact the company

Recalling firmAsclemed USA Inc. dba Enovachem379 Van Ness Ave Ste 1403 · Torrance, CA 90501-7211
✎ GovInfoNow plain-language explainer

Enovachem is recalling Dyural-40 Injection Kits because the stoppers contain natural rubber latex, which the product label incorrectly stated did not contain latex. This could cause allergic reactions in people sensitive to latex. Read more at govinfonow.com/recall/39371-enovachem-dyural-40-injection-kit-recall-latex-in-stopper.

Source Summary by GovInfoNow · govinfonow.com/recall/39371-enovachem-dyural-40-injection-kit-recall-latex-in-stopper · Updated October 5, 2026 · FDA enforcement record: FDA #D-0353-2019

Cite this page

“Enovachem Dyural-40 Injection Kit Recall: Latex in Stopper.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39371-enovachem-dyural-40-injection-kit-recall-latex-in-stopper. Based on FDA recall #D-0353-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0353-2019%22&limit=1).

The FDA announced on Dec. 11, 2018, that Enovachem recalled Dyural-40 Injection Kits because the product insert incorrectly stated the stoppers did not contain latex, while they actually do. The agency classified the recall as Class I.

How to tell if you have it

  • Brand: Enovachem
  • Product: Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only
  • NDC: 76420-0750-01
  • Lots: 050518X5, 051618X1 (Exp 1/31/19); 052318X4 (Exp 5/1/19); 052318X5, 062818X1, 072518X3, 072718X1, 080318X2, 091818X2 (Exp 5/31/19); 082318X4, 083118X1, 090518X4, 091818X4 (Exp 6/30/19); 091818X3 (Exp 7/31/19); 091818X5, 092418X1, 092818X4, 101018X3, 101018X5 (Exp 8/31/19); 102418X5 (Exp 9/30/19)
  • Distribution: U.S.A. Nationwide

The hazard

The kits include Sodium Chloride, USP, 0.9%, which was recalled by the manufacturer because the product insert incorrectly stated that the stoppers do not contain latex. The stoppers actually contain natural rubber latex.

Context

Other recent recalls of similar products include Teva Clonidine Transdermal System Recall (2026-03-19), Lupin Liraglutide 18mg/3mL Injection Recall (2026-04-24), and Cipla Lanreotide Injection Recall (2026-03-13).

How to tell if you have this one

Check the lot numbers listed in the recall: 050518X5, 051618X1, 052318X4, and others. The kits are distributed by Enovachem Pharmaceuticals in Torrance, CA.

  • Brand
    Enovachem
  • Category
    Drug
FDA recall event · 2 products

All 2 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 I
  • Status
    Terminated
  • Distribution
    U.S.A. Natonwide
Recall numberProduct, codes & lotsQuantity
D-0353-2019Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01; Lot #: 050518X5, 051618X1, Exp 1/31/19; 052318X4, Exp 5/1/19; 052318X5, 062818X1, 072518X3, 072718X1, 080318X2, 091818X2, Exp 5/31/19; 082318X4, 083118X1, 090518X4, 091818X4, Exp 6/30/19; 091818X3, Exp 7/31/19; 091818X5, 092418X1, 092818X4, 101018X3, 101018X5, Exp 8/31/19; 102418X5, Exp 9/30/19—
D-0354-2019Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01; Lot # 050918X1, 051618X10, 051818X4, Exp 12/31/18; 071718X2, Exp 2/28/19; 061118X8, Exp 5/1/19; 051518X4, 051818X5, 052118X4, 052118X5, 052918X7, 061118X9, 061118X10, 061418X2, 061518X1, Exp 5/31/19; 061518X2, 061918X2, 062518X2, 062718X1, 062718X2, 062818X3, 062818X4, 070918X1, 071018X5, 071118X4, 071118X5, 072018X6, 072418X3, 072418X4, 072518X2, 073018X4, 073018X8, 080218X3, 080718X7, 080918X3, 083018X2, 083118X2, 083118X5, 090518X5, Exp 6/30/2019; 090518X6, 090718X2, 090718X3, 090718X5, 091118X7, 091318X5, 091918X1, 092718X1, 092718X2, 092818X3, 100518X6, 101118X3, 101518X2, 101618X7, 101618X8, 101818X3, 101918X1, 102318X1, 103118X1, 103118X2, Exp 7/31/19; 103118X3, 110618X1, 110818X1, Exp 9/30/19—
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Lot Number

    Look for the lot numbers listed in the recall: 050518X5, 051618X1, 052318X4, and others.

How this recall unfolded

Recall timeline

FDA terminated this recall 4.1 years after the firm started it.

1. Firm started the recall: Dec 11, 201812. Published in FDA’s Enforcement Report: Dec 26, 201823. FDA classified it Class I: Jan 9, 201934. FDA terminated the recall: Feb 1, 2023420182023
  1. Firm started the recall
  2. Published in FDA’s Enforcement Report
  3. FDA classified it Class I
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury?

The recall is for potential allergic reactions in latex-sensitive individuals, not a risk of serious injury.

Similar recalls

Preferred Pharma Recalls Lidocaine Ointment Due to Content Issues
Preferred Pharmaceuticals, Inc.Northstar Rx Recalls Tretinoin Cream Due to Impurities
SUN PHARMACEUTICAL INDUSTRIES INCApothecary Pharma Recalls Tirzepatide Injections Due to Sterility Risk
Apothecary Pharma LLCApotex Recalls Paroxetine 37.5mg Due to Dissolution Failure
Apotex Corp.Cipla Recalls Fosfomycin Tromethamine Granules Due to Impurities
Cipla USA, Inc.

Latest drug recalls

Ajanta Pharma USA Inc recalls Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc.,
Ajanta Pharma · September 17, 2026Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company recalls Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with
Insight Pharmaceuticals · September 15, 2026K.C. Pharmaceuticals, Inc. recalls Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO
Leader / TopCare / Crocodile Tears · September 11, 2026Amneal Pharmaceuticals, LLC recalls Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater,
Amneal Pharmaceuticals · September 8, 2026Inventia Healthcare Limited recalls Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC:
Inventia Healthcare · September 3, 2026SV Labs Toronto Corporation recalls Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL)
SV Labs · September 1, 2026

Keep exploring

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-0353-2019 (December 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0353-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA