The Recall Desk

Hazard

Out Of Specification Assay recalls

6 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2026-05-06

Of the 6 out of specification assay recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all out of specification assay recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–6 of 6

  • ModerateFDA (Drugs)·D-0526-2026·2026-05-06

    Alendronate Sodium Oral Solution Recalled for Out-of-Specification Assay Results

    Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution 70 mg/75 mL due to out-of-specification assay results found in a limited number of bottles. The affected lot (AC2040A) was distributed nationwide.

    Product
    ALENDRONATE SODIUM — ALENDRONATE SODIUM (ALENDRONATE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0640-2022·2022-03-02

    Sapropterin Dihydrochloride Powder Recall for Subpotent Drug

    Dr. Reddy's Laboratories is recalling Sapropterin Dihydrochloride Powder for Oral Solution (100 mg) nationwide due to out-of-specification assay results indicating the product contains less active ingredient than labeled.

    Product
    Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0460-2022·2022-01-19

    Sufentanil Citrate Injection Recalled for Subpotency

    Akorn, Inc. is recalling Sufentanil Citrate Injection 100 mcg/2 mL due to subpotency—the drug was found to be out of specification for assay at the 30-month stability timepoint. Affected lot 031489A, with expiration 03/31/2022, was distributed nationwide.

    Product
    Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0234-2022·2021-11-24

    Flocinolone Acetonide 0.01% Topical Oil Recalled for Subpotent Drug

    Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil because testing found out-of-specification assay results, meaning the drug may contain less active ingredient than labeled.

    Product
    Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86
    Category
    Drug
    Distribution
    Distributed nationwide