The Recall Desk

Hazard

Product Stability recalls

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

What the numbers show

Total
19
Critical
0
Severe
1
Most recent
2023-01-18

Of the 19 product stability recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all product stability 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.

1–19 of 19

  • ModerateFDA (Drugs)·D-0101-2023·2023-01-18

    Moxifloxacin Ophthalmic Solution Recalled Due to Manufacturing Quality Deviation

    Direct Rx recalled 11 bottles of Moxifloxacin Ophthalmic Solution (0.5%, 3 mL) due to a cGMP deviation and discontinued stability support.

    Product
    Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1099-2022·2022-06-15

    Drug recall: Thrombin JMI injection kits due to manufacturing temperature deviation

    McKesson Medical-Surgical is recalling 157 kits of Thrombin JMI nationwide due to temperature exposure during manufacturing that may have affected product quality and efficacy.

    Product
    Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-215-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1036-2022·2022-06-15

    FDA Recalls MIOSTAT Carbachol Solution Nationwide for Temperature Abuse

    McKesson Medical-Surgical is recalling MIOSTAT (Carbachol Intraocular Solution) nationwide due to temperature abuse during distribution that may affect medication stability.

    Product
    MIOSTAT — MIOSTAT (CARBACHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0286-2022·2021-12-08

    Sandoz Enoxaparin Sodium Injection Recalled Due to Temperature Excursion

    Sandoz Inc. is recalling 45,036 cartons of Enoxaparin Sodium Injection USP 40 mg/0.4 mL due to temperature abuse during shipping. The affected lot was distributed nationwide.

    Product
    Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen T
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0068-2022·2021-11-03

    Loratadine-D Extended-Release Tablets Recalled for Failed Moisture Limits

    Sun Pharmaceutical Industries is recalling 22,752 blister packs of Loratadine-D Extended-Release Tablets (10mg/240mg) distributed nationwide due to failed moisture limits. The affected lot is AC14635 with expiration date 12/2022.

    Product
    LORATADINE AND PSEUDOEPHEDRINE SULFATE — LORATADINE AND PSEUDOEPHEDRINE SULFATE (LORATADINE AND PSEUDOEPHEDRINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2021·2021-07-28

    NaturaLyte Bicarbonate Concentrate Recalled After Freezing Temperature Exposure

    NaturaLyte Dry Bicarbonate Concentrate, used in hemodialysis machines to prepare dialysate, was recalled after exposure to freezing temperatures during transport. The affected lot (21ATBC004) was distributed to facilities in Texas only.

    Product
    NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formula
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0610-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Abuse

    Fresenius Medical Care is recalling 285 cases of DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0529-2021·2021-06-02

    Cardinal Health Recalls Proctofoam Aerosol Due to Temperature Excursions

    Cardinal Health is recalling 834 containers of Proctofoam HC aerosol due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    PROCTOFOAM — PROCTOFOAM (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2874-2018·2018-08-29

    BioMérieux VITEK 2 NH ID Test Kit Recalled for Missing Desiccant

    BioMérieux Inc. is recalling 57 cartons of VITEK 2 NH ID Test Kits because they are missing desiccant, which may affect product stability.

    Product
    bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0925-2018·2018-07-18

    Sanofi Recalls Admelog Insulin Pens Due to Temperature Abuse

    Sanofi-Aventis is recalling 3,214 Admelog insulin pens because they may not have been shipped at the proper temperature.

    Product
    ADMELOG — ADMELOG (INSULIN LISPRO)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2170-2018·2018-06-20

    BioMérieux PREVI Color Gram Reagents Recalled Due to Temperature Excursion

    BioMérieux is recalling PREVI Color Gram reagents shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

    Product
    The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have b
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1524-2017·2017-03-29

    BioMerieux Recalls ETEST Ciprofloxacin CI 32 Foam Due to Stability Issues

    BioMerieux SA is recalling ETEST Ciprofloxacin CI 32 Foam products because their shelf-life claims are not supported by internal testing.

    Product
    Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2017·2017-03-29

    BioMerieux Recalls ETEST Imipenem IP32 Foam Packaging Due to Stability Issues

    BioMerieux SA is recalling ETEST Imipenem IP32 Foam packaging because the current shelf-life claims are not supported by internal testing.

    Product
    ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entero
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1501-2014·2014-08-06

    Daiichi Sankyo Recalls Azor Tablets Due to Temperature Abuse During Shipping

    Daiichi Sankyo is recalling 5 bottles of Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg/40 mg because they were not stored at controlled room temperature during shipping.

    Product
    Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1504-2014·2014-08-06

    Daiichi Sankyo Recalls Tribenzor Tablets Due to Temperature Abuse

    Daiichi Sankyo is recalling specific lots of Tribenzor tablets because they were not stored at controlled room temperature during shipping.

    Product
    Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-419-2013·2013-05-29

    Rite Aid Tussin Cough Syrup Recalled for Precipitate Presence

    Aaron Industries is recalling Rite Aid brand Tussin Cough & Cold Mucus Relief CF due to the presence of white precipitate, identified as the active ingredient guaifenesin.

    Product
    Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-086-2013·2012-12-12

    Taro Recalls Fluorouracil Topical Cream Due to Stability Issues

    Taro Pharmaceuticals is recalling Fluorouracil Topical Cream 5% because out-of-specification results were found in retain samples.

    Product
    FLUOROURACIL — FLUOROURACIL (FLUOROURACIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1696-2012·2012-10-03

    Abbott Recalls Synthroid Tablets Due to Defective Bottle Bottoms

    Abbott Laboratories is recalling 40,464 bottles of Synthroid (levothyroxine sodium) 112 mcg tablets nationwide. The recall addresses a localized thin wall defect on the bottom of some bottles that may impact tablet stability.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide