FDA recall, , Low risk
Greer Laboratories Sterile Diluent for Allergenic Extract
Sterile Diluent for Allergenic Extract, Normal Saline has a lower than expected phenol level.
Greer Laboratories began this recall on Apr 14, 2026. FDA posted it on Oct 28, 2026; it is still open.
Summary by Recall Canary from the FDA notice
What happened
Greer Laboratories, Inc., of Lenoir, North Carolina, is voluntarily recalling Sterile Diluent for Allergenic Extract, Normal Saline, Item No. SD2507001, because an out of specification (OOS) phenol level, lower than expected, was identified during routine stability testing. The recall was initiated on April 14, 2026, and was added to the FDA's Enforcement Report on October 28, 2026.
The recall affects 3,500 vials distributed nationwide in the US, including Oregon, Pennsylvania, Tennessee, Mississippi, Wisconsin, South Carolina, North Dakota, Texas, and New Hampshire. Customers were notified by letter.
What to do
Allergenic extracts are used by allergists and other doctors for allergy skin tests and allergy shots. If you had allergy testing or get allergy shots, ask the office that treats you whether this product was used. If they contact you, follow their advice.
What was recalled
Allergists' offices and clinics match these details against their records.
Sterile Diluent for Allergenic Extract, Normal Saline
- Item number
- SD2507001
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Distributed to
Nationwide in US: OR, PA, TN, MS, WI, MS, TN, SC, ND, TX, NH.
- Recalled by
- Greer Laboratories, Inc.Lenoir, North Carolina
- Hazard
- Quality testing problem
- Risk
Low risk
Its use is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- FDA event number
- 99054
- Recall number
- B-0020-2027
- Quantity recalled
- 3,500 vials
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Greer Laboratories, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Greer Laboratories began the recall
FDA posted the recall to its Enforcement Report and rated it Class III (low risk)
Added to Recall Canary
Summary updated
