The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

3401–3425 of 3531

  • ModerateFDA (Drugs)·D-0729-2021·2021-08-25

    Acetaminophen 325 mg tablets recalled for discoloration and cGMP deviations

    Spirit Pharmaceuticals is recalling Acetaminophen 325 mg Regular Strength Pain Reliever tablets due to discoloration and current good manufacturing practice (cGMP) deviations. The recall affects one lot distributed nationwide.

    Product
    Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0876-2021·2021-08-25

    Chicken of the Sea Genova Meal Kits recalled for quality standards

    Chicken of the Sea is recalling promotional Genova Meal Kits because products included in the kits were prepared in a home kitchen that did not meet quality standards.

    Product
    Chicken of the Sea Genova Meal Kit; Kits include dry whole wheat pasta, dried basil and parsley, 2 cans of Genova Tuna, pesto, Kalamata olives, sundried tomatoes, dates.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0728-2021·2021-08-25

    Avicel Microcrystalline Cellulose Recall for Out-of-Specification Conductivity

    DuPont Nutrition USA, Inc. is recalling Avicel microcrystalline cellulose (bulk PH101 NF, PH102 NF, PH200 NF) due to out-of-specification conductivity results. The product was distributed nationwide and internationally.

    Product
    Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0725-2021·2021-08-25

    Combipatch Transdermal Patch Recall Due to Stability Failure

    Noven Pharmaceuticals is recalling certain lots of Combipatch (estradiol/norethindrone acetate transdermal system) distributed nationwide because the patches failed stability testing and fell out of specification for shear properties.

    Product
    COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0724-2021·2021-08-25

    Combipatch Transdermal System Recalled for Failed Stability Specifications

    Noven Pharmaceuticals is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day because certain lots failed stability specifications and tested out of specification for shear.

    Product
    COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0752-2021·2021-08-25

    Triamcinolone Acetonide Ointment Mispack Recall by Teligent Pharma

    Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% due to a labeling mispack affecting Lot #16630 with expiration 03/2023. The recall was issued due to incorrect labeling on the product.

    Product
    Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; packaged in tubes.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0912-2021·2021-08-25

    HiPP HA Infant Formula Recalled for Missing Pre-Market Notification

    Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling.

    Product
    HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0751-2021·2021-08-25

    Econazole Nitrate Cream 1% recalled due to labeling mispack

    Teligent Pharma is recalling Econazole Nitrate Cream 1% in 85-gram bulk tubes due to incorrect labeling. The product was distributed nationwide.

    Product
    Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0726-2021·2021-08-25

    Gavilyte-C Oral Solution Recalled for Failed Stability Specification

    Novel Laboratories/Lupin Pharmaceuticals is recalling Gavilyte-C (polyethylene glycol-3350 and electrolytes with flavor pack) due to failed stability testing and out-of-specification osmolarity. The product is distributed nationwide.

    Product
    GAVILYTE - C — GAVILYTE - C (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0727-2021·2021-08-25

    Cholestene Capsules Recalled for Marketing Without Approved Application

    High Performance Formulas is recalling Cholestene capsules (red yeast rice supplement, 1200 mg per 2 capsules, 120-count bottles) because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0913-2021·2021-08-25

    HiPP HA Infant Formula Recalled for Missing FDA Premarket Notification and Labeling

    Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula because required FDA premarket notifications were not submitted and products lack mandatory English labeling as required by federal regulations.

    Product
    HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0719-2021·2021-08-18

    Sulfamethoxazole and Trimethoprim Tablets Recalled for Metal Contamination

    Aurobindo Pharma USA Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) due to potential metal contamination in the product. The recall affects approximately 3,800 bottles distributed nationwide.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0723-2021·2021-08-18

    Ethosuximide Oral Solution Recalled Due to Lack of CGMP Compliance

    PAI Holdings is recalling Ethosuximide Oral Solution 250 mg/5 mL (Lot C9BC, expiration 31 October 2022) distributed nationwide due to potential carry-over contamination from Senna Syrup related to lack of current good manufacturing practices.

    Product
    ETHOSUXIMIDE — ETHOSUXIMIDE (ETHOSUXIMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0860-2021·2021-08-18

    Monfefo Turmeric Shot Recalled Due to Manufacturing Non-Compliance

    Monfefo LLC is recalling Monfefo brand Turmeric Shot in 2oz glass bottles because the product was not manufactured according to specifications. Affected lots were distributed across multiple states.

    Product
    Monfefo brand Turmeric Shot; 2oz; Cold Pressed Juice Blend; packaged in glass bottle
    Category
    Food
    Distribution
    19 states
  • ModerateCPSC·21185·2021-08-18

    Primark Recalls 8-Pack Scent Stamper Pens for Elevated Benzyl Alcohol

    Primark is recalling about 9,500 8-pack Scent Stamper Pens due to elevated levels of benzyl alcohol in the purple pen, which poses a risk of skin irritation. No injuries have been reported.

    Product
    8-Pack Scent Stamper Pens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0703-2021·2021-08-18

    Venlafaxine 50 mg Tablets Recalled for Wrong Strength

    SUN PHARMACEUTICAL INDUSTRIES INC is recalling Venlafaxine Tablets labeled as 50 mg because bottles contain Venlafaxine 37.5 mg tablets, creating a dosing error risk.

    Product
    Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2227-2021·2021-08-18

    CIRRUS HD-OCT Model 6000 imaging devices recalled for missing FDA pre-market clearance

    Carl Zeiss Meditec is recalling 914 CIRRUS HD-OCT Model 6000 imaging devices. The manufacturer failed to obtain FDA pre-market clearance before selling the devices.

    Product
    Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-2241-2021·2021-08-18

    Kaluza C Flow Cytometry Software Recalled for Potential Erroneous Results

    The FDA is recalling Kaluza C Flow Cytometry Software versions 1.0, 1.1.1, and 1.1.2 due to software anomalies that may generate erroneous results affecting diagnostic interpretation.

    Product
    Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0720-2021·2021-08-18

    Zyprexa Intramuscular Injection Recalled for Manufacturing Defects

    Eli Lilly is recalling 36,540 vials of Zyprexa (olanzapine) 10 mg intramuscular injection due to manufacturing deviations affecting the drug product's appearance, size, and color.

    Product
    ZYPREXA — ZYPREXA (OLANZAPINE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0722-2021·2021-08-18

    Cimetidine Hydrochloride Oral Solution Recalled for CGMP Violation

    Pharmaceutical Associates Inc. is recalling Cimetidine Hydrochloride Oral Solution 300 mg/5 mL due to a lack of Current Good Manufacturing Practice (CGMP) and potential carryover of Senna Syrup.

    Product
    Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2210-2021·2021-08-18

    InTouch 2131 Medical Device Recalled for Distribution to Residential Users

    Stryker's InTouch 2131 medical device, intended for healthcare facilities, was distributed to residential customers. Home users may not understand healthcare-specific instructions, creating a risk of improper use.

    Product
    InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2209-2021·2021-08-18

    Prime TC Transport Chair Recalled for Improper Residential Distribution

    The Prime TC-transport chair, designed for healthcare facility use, was distributed to residential customers who may not understand the professional-level operating instructions. The recall addresses potential risk of improper use by home users.

    Product
    Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do Model Number: 1460, Part #1460000000¿¿¿¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2233-2021·2021-08-18

    Medline Total Knee Surgical Kit Recalled for Expired Irrigation Component

    Medline Industries is recalling Total Knee convenience kits that may contain an expired saline irrigation solution component. The expired component may not maintain proper sterility for surgical use.

    Product
    Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0721-2021·2021-08-18

    Nystatin Oral Suspension Recalled Due to CGMP Violation

    PAI Holdings is recalling Nystatin Oral Suspension nationwide due to a lack of Current Good Manufacturing Practice (CGMP) controls that could allow carryover of Senna Syrup into the product.

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