The Recall Desk

Hazard

Stability Failure recalls

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

What the numbers show

Total
188
Critical
0
Severe
9
Most recent
2026-09-02

Of the 188 stability failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (5%) 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 stability failure 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.

1–25 of 188

  • ModerateFDA (Drugs)·D-0804-2026·2026-09-02

    Apotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing

    Apotex Corp. is recalling 6,972 bottles of Paxil CR 37.5mg tablets because the product failed dissolution specifications and 24-month stability testing.

    Product
    PAXIL — PAXIL (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0385-2026·2026-03-11

    Vasocaine lidocaine spray recalled because stability data does not support expiry

    HTO Nevada, trading as Kirkman, is recalling Five-Star Vasocaine Spray because the stability data does not support the labeled expiry date.

    Product
    FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0387-2026·2026-03-11

    Zone 2 lidocaine cream recalled because stability data does not support expiry

    HTO Nevada, trading as Kirkman, is recalling one lot of Maximum Zone 2 4% Lidocaine Cream because the stability data does not support the labeled expiry date.

    Product
    MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2026·2026-03-11

    Zone 1 lidocaine cream recalled because stability data does not support expiry

    HTO Nevada, trading as Kirkman, is recalling one lot of Maximum Zone 1 4% Lidocaine Cream because the stability data does not support the labeled expiry date.

    Product
    MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0237-2026·2025-12-24

    Cisatracurium 200 mg vials recalled after subpotent stability assay results

    Somerset Therapeutics is recalling 28,660 vials of Cisatracurium Besylate Injection, 200mg/20mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0240-2026·2025-12-24

    Ciclopirox shampoo recalled after failing impurity specifications at eighteen months

    Sun Pharma/Taro is recalling 17,664 units of Ciclopirox Shampoo 1% after out of specification impurity and degradation results at the 18-month timepoint.

    Product
    Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0238-2026·2025-12-24

    Cisatracurium 20 mg multiple-dose vials recalled after subpotent assay results

    Somerset Therapeutics is recalling 71,310 vials of Cisatracurium Besylate Injection, 20 mg/10 mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0236-2026·2025-12-24

    Cisatracurium 10 mg vials recalled after subpotent stability assay results

    Somerset Therapeutics is recalling 52,340 vials of Cisatracurium Besylate Injection, 10 mg/5 mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0219-2026·2025-12-17

    Varenicline tablets recalled after an assay value fell below specification

    Dr. Reddy's Laboratories is recalling 4,800 bottles of Varenicline Tablets, 1mg, after the assay value for the affected lot fell below the specification limit at nine-month stability testing.

    Product
    VARENICLINE TARTRATE — VARENICLINE TARTRATE (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0217-2026·2025-12-17

    Lanthanum carbonate tablets recalled in a second hardness specification failure

    Cipla USA is recalling 1,180 boxes of Lanthanum Carbonate chewable tablets, 1000mg, from a further lot after an out of specification hardness test result.

    Product
    LANTHANUM CARBONATE — LANTHANUM CARBONATE (LANTHANUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2026·2025-11-05

    Nasal test kits recalled after a false negative on a positive sample

    Cepheid is recalling 4,132 Xpert SA Nasal Complete kits after post-market half-time stability testing produced a false negative result for a positive sample type.

    Product
    Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0150-2026·2025-11-05

    Lisdexamfetamine 70 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 70 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0148-2026·2025-11-05

    Lisdexamfetamine 50 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 50 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0145-2026·2025-11-05

    Lisdexamfetamine 20 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 20 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0147-2026·2025-11-05

    Lisdexamfetamine capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 40 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0144-2026·2025-11-05

    Lisdexamfetamine 10 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 10 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0149-2026·2025-11-05

    Lisdexamfetamine 60 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 60 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0146-2026·2025-11-05

    Lisdexamfetamine 30 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 30 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0031-2026·2025-10-29

    Gabapentin blister packs recalled after unknown impurity exceeded specification

    The Harvard Drug Group is recalling Gabapentin Capsules USP 100 mg in 10-capsule blister packs after routine stability testing returned an out-of-specification result for highest unknown impurity.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide