Subpotent compounded injection (D-0548-2026) — too little of the active ingredient is a reason for recall as much as too much
A compounded analgesic injection recalled as subpotent. Where the active ingredient is less than intended, the problem takes the form of the expected effect not being achieved. The quantity is 376 cassettes.
Recall overview (primary data)
- ClassificationClass II
- Product typeDrug
- Recalling firmIntegraDose Compounding Services LLC
- ReasonSubpotent Drug
- DistributionNationwide.
- Recall initiated2026-05-12
Key points
- A compounded analgesic injection was recalled as subpotent.
- Where the active ingredient falls short, the problem takes the form of the expected effect not being achieved.
- A shortfall presents as the medicine not working, so the cause is not readily distinguished at the time.
- The product was prepared to an individual requirement, and such small-volume work assures quality differently than bulk manufacture.
- At 376 cassettes the quantity is small, but compounded injections may already have been used before notice arrives.
1Too little as the problem
A drug recall brings to mind something harmful mixed in, or too much of an ingredient. The reverse also occurs. Where the active ingredient falls short of what was intended, the expected effect does not follow. For a medicine given to control pain, the pain is not controlled.
A shortfall presents to the person treated as the medicine not working. Whether the cause lies in potency or in the condition or constitution of the patient is not readily distinguished at the time. Being hard to notice characterises this class.
2What compounding is
- 1Manufactured medicinesMade at a production site to a set specification
- 2Compounded medicinesPrepared to meet an individual requirement
- 3The product hereAn injection prepared in the form a clinical setting requires
- 4The nature of the workHighly individual, with little room for economies of scale
The firm here prepares medicines. Where an off-the-shelf product cannot supply a needed concentration or volume, preparation is done individually. Being highly individual, the work runs in small volumes across many variants, and quality is assured differently than where one specification is made in bulk.
3Quantity and distribution
At 376 cassettes the quantity is small among the records this site holds as of 2026-09-04. Compounded injections, however, are used directly in clinical settings. They may not sit on a shelf as a retail product would, and may already have been used before notice of a recall arrives. A small quantity does not by itself mean a small effect.
4What the record does and does not say
The product is an injection of a strongly acting analgesic, where a shortfall means the required pain relief is not obtained. Such medicines are also handled in a field where dosing is managed strictly. A recall record states the reason and the quantity; it does not record whether harm actually occurred. What this site organizes is likewise the fact that a recall took place.
Why it matters
A small quantity does not mean a small effect. Individually compounded preparations are used directly in clinical settings, so a recall must assume some have been used before notice arrives.
FAQ
Is too little an ingredient a recall reason?
Why is it hard to notice?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: D-0548-2026