Fentanyl Injection Syringes Recalled for Subpotent Active Ingredient
SCA Pharmaceuticals is recalling 2,125 fentanyl injection syringes nationwide due to subpotency—the product contains less active ingredient than labeled. The firm voluntarily initiated this Class III recall in February 2023.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is classified as FDA Class III, the lowest-risk classification for drug recalls. The recall was voluntary and firm-initiated with no reported illnesses, injuries, or adverse events. The hazard is a pharmaceutical quality issue (subpotency) without evidence of patient harm.
Plain-English summary
SCA Pharmaceuticals, Windsor, Connecticut, is recalling 2,125 fentanyl 1,500 mcg/30 mL injection syringes. The affected product is for intravenous use, preservative-free, with a concentration of 50 mcg/mL in a single-dose container. Five lot numbers are involved with expiration dates ranging from March 29, 2023 to May 4, 2023.
The recall was initiated because the syringes contain less active pharmaceutical ingredient than the labeled amount, a condition known as subpotency. SCA Pharmaceuticals voluntarily reported this issue on February 24, 2023, and the FDA assigned a Class III classification on February 28, 2023. Class III recalls are for products with minimal potential health risk.
The affected product was distributed nationwide throughout the United States. The recall was completed and terminated on June 21, 2023.
The recalled product
- Product
- Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Analgesic
- Hazard
- subpotent-drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot # 1222043351
- exp. date 03/29/2023 1222043387
- exp. date 04/05/2023 1222043352
- exp. date 04/05/2023 1222043463
- exp. date 04/06/2023 1223043922
- exp. date 05/04/2023
Distribution
Distributed nationwide across the United States.
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