CLASS II ONGOING Drug recall · Reported 15 Oct 2025 · FDA Enforcement Report
Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalled
Dr. Reddy's Laboratories is recalling Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL), mL Multiple-Dose Vials, For, distributed nationwide in the US. The recall was initiated on 26 Sep 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0008-2026
- FDA event ID
- 97690
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Succinylcholine
- Manufacturer
- Dr.Reddy's Laboratories Inc.,
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Sep 2025
- FDA classified
- 7 Oct 2025
- Reported
- 15 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Sep 2025 | Recall initiated by company | |
| 7 Oct 2025 | Classified by FDA | +11 days |
| 15 Oct 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25
Where it was distributed
Nationwide within the USA.
Questions about this recall
Why was it recalled?
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Which lots are affected?
Lot # K250048
Where was it sold?
Nationwide within the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Other | Nationwide |
Other Succinylcholine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | succinylcholine, 200 mg/, (20 mg/mL) syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | succinylcholine 200 mg/ (20 mg/mL), Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | succinylcholine, 200 mg/, (20 mg/mL) syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Succinylcholine 20 MG/ML INJ (Quelicin) Vials recalled | Ace Surgical Supply | Other | Nationwide |
| Drug | CLASS II | Succinylcholine 200 mg/ Syringe recalled by Banner Pharmacy Services | Banner Pharmacy Services | Sterility | Nationwide |