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FDA recall, , Low risk

Greer Laboratories Sterile Diluent for Allergenic Extracts Normal Saline

Retention samples from this lot exhibited evidence of glass delamination.

What happened

Greer Laboratories, Inc., of Lenoir, North Carolina, is voluntarily recalling Sterile Diluent for Allergenic Extracts Normal Saline, 2.0 mL, Item No. SD2507001. The company began the recall on August 25, 2026, after retention samples from this lot exhibited evidence of glass delamination. The recall involves 200 vials and was added to the FDA's Enforcement Report on October 29, 2026.

The product was distributed in South Carolina and Wisconsin. Customers were notified by letter. The recall was classified by the FDA on October 29, 2026, and in the FDA's weekly enforcement report on November 4, 2026.

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.

  1. Sterile Diluent for Allergenic Extracts Normal Saline, 2.0 mL, Item No. SD2507001

    Unit number
    • 440967
    Recall number
    B-0022-2027
  2. Item number
    • SD2507001

Recall details

Posted by FDA
Recall began
Status
Open
Recalled by
Greer Laboratories, Inc.Lenoir, North Carolina
Risk

Low risk

Its use is unlikely to cause health problems.

FDA Class III recall · How risk is rated

FDA event number
99771
Recall number
B-0022-2027
Quantity recalled
200 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.

  1. Greer Laboratories began the recall

  2. FDA posted the recall to its Enforcement Report and rated it Class III (low risk)

  3. Added to Recall Canary

  4. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 31, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)