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.

3301–3325 of 3531

  • ModerateFDA (Drugs)·D-0882-2021·2021-10-06

    Z-1020 Formula Homeopathic Medicine Recall for Failed Identification Testing

    Washington Homeopathic Products is recalling Z-1020 Formula due to out-of-specification test results on identification testing. The product was distributed nationwide.

    Product
    Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Baryta Carbonica 10X, Chromium Sulphuricum 10X, Crataegus Oxyacantha 10X, Digitalis Purpurea 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilu
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2021·2021-10-06

    Neutrogena COOLDRY SPORT Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY (5.5 oz, SPF 50) due to cGMP (current Good Manufacturing Practice) deviations. Approximately 1.4 million cans distributed nationwide are affected.

    Product
    Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%, Homosalate 5%, Octisalate 4.5%, Octocrylene 6%, Oxybenzone 4.5%. NET WT. 5.5 OZ. (155 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0889-2021·2021-10-06

    Strophanthus Hisp 30X Homeopathic Medicine Fails Identification Test

    Washington Homeopathic Products is recalling 91 bottles of Strophanthus hisp 30X for Hives due to failed identification testing. The product did not meet specifications in HPTLC analysis and was distributed nationwide.

    Product
    Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 40640 47553 9; (b) 30mL UPC 7 40640 47557 7; (c) 100mL, UPC 7 40640 47565 2; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0877-2021·2021-10-06

    Washington Homeopathic Products Quebracho 4C Fever Medicine Recall

    Washington Homeopathic Products is recalling Quebracho 4C Fever homeopathic medicine (Lot #28930, expiration 8/17/2026) distributed nationwide due to out-of-specification test results from identification testing.

    Product
    Quebracho 4C, Fever*, 20% Alcohol, Packaged as 100ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0836-2021·2021-10-06

    Neutrogena Ultra Sheer Sunscreen Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 30 due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 1.6 million cans distributed nationwide.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 10038 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0893-2021·2021-10-06

    Aconitum Napellus Fear Pills Recalled for Failed Quality Testing

    Washington Homeopathic Products is recalling Aconitum Napellus Fear homeopathic pills in multiple potencies and package sizes (562 bottles, Lot #26198) distributed nationwide because test results showed out-of-specification identification results on HPTLC analysis.

    Product
    Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X, 9X, 12X,30X, packaged in 1 oz containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 10X, 15X, 24X, 30X, packaged in 2 dr containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 30X, packaged in 2 oz
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0852-2021·2021-10-06

    Drug recall: Daytime/Nighttime Severe Cold & Flu Relief vials subpotent

    New Vision Pharmaceuticals is recalling Daytime and Nighttime Severe Cold & Flu Relief single-use vials because the drug is subpotent—meaning it contains less active ingredient than intended. The recall was initiated voluntarily on September 2, 2021.

    Product
    Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057
    Category
    Drug
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2520-2021·2021-09-29

    Decompression Needle Recall Due to Incorrect Instructions for Use

    North American Rescue is recalling 51,424 units of 10 ga ARS Decompression Needles due to incorrect Instructions for Use. Affected parties should stop using and contact manufacturer.

    Product
    10 ga ARS Decompression Needle, Part Number ZZ-0298
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2496-2021·2021-09-29

    Ad-Tech TECH ATTACH Cable Recalled Due to Incorrect Labeling

    Ad-Tech Medical Instrument Corporation is recalling TECH ATTACH Cables due to incorrect labeling. The cables connect electrodes to third-party monitors and stimulators.

    Product
    Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0821-2021·2021-09-29

    Glenmark Naproxen Sodium Tablets recalled for CGMP deviations

    Glenmark Pharmaceuticals is recalling 9,552 bottles of Naproxen Sodium Tablets USP 275 mg nationwide due to CGMP (current Good Manufacturing Practice) deviations identified at the manufacturing facility.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0814-2021·2021-09-29

    Promethazine Syrup Plain Recall Due to Microbial Contamination

    Morton Grove Pharmaceuticals is recalling Promethazine Syrup Plain 6.25 mg/5 mL in 1-pint bottles due to potential microbial contamination in liquid sugar batches used during manufacturing.

    Product
    Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0822-2021·2021-09-29

    Glenmark Naproxen Sodium 550 mg Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals is recalling specific lots of Naproxen Sodium 550 mg tablets nationwide due to manufacturing deviations. The firm initiated the voluntary recall on August 27, 2021.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0813-2021·2021-09-29

    Sirolimus Tablets Recalled for Failed Impurities and Degradation Specifications

    American Health Packaging is recalling Sirolimus 1 mg tablets (Lot #1000789, expiring 10/31/2022) distributed nationwide because they failed impurities and degradation specifications.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0818-2021·2021-09-29

    Hydroquinone Skin Bleaching Cream Recalled for Subpotency Issues

    Monarch PCM, LLC is recalling Hydroquinone 4% Skin Bleaching Cream due to subpotency affecting the active ingredient assay and preservative assay in one product each.

    Product
    HYDROQUINONE — HYDROQUINONE (HYDROQUINONE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Food)·F-0999-2021·2021-09-29

    Phillips Majestic Blue Crab Meat Recall Due to Temperature Control

    Sysco Atlanta is recalling Phillips Majestic Blue pasteurized crab meat because the product was not held at appropriate temperatures and may be unsafe to consume.

    Product
    Phillips Majestic Blue Colossal Clawfingers 20/40 6/12 oz CANS UPC 10070057145068 & Phillips Majestic Blue Large Clawfingers 50/70 6/12oz CANS UPC 10070057145167 PASTEURIZED PREMIUM CRAB MEAT WILD CAUGHT KEEP REFRIGERATED
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0809-2021·2021-09-29

    Pfizer recalls Chantix tablets for N-nitroso-varenicline impurity

    Pfizer is recalling certain lots of Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0806-2021·2021-09-29

    Entacapone Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Entacapone 200 mg tablets distributed in Colorado, Florida, Missouri, and Ohio due to failed dissolution specifications that may affect drug efficacy.

    Product
    ENTACAPONE — ENTACAPONE (ENTACAPONE)
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2495-2021·2021-09-29

    Ad-Tech TECH ATTACH Cable Recalled for Incorrect Label Information

    Ad-Tech Medical recalled its Lightweight TECH ATTACH Cable due to incorrect labels on affected units. The cables are designed to connect electrodes to third-party monitors and stimulators.

    Product
    Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0817-2021·2021-09-29

    Sodium Sulfacetamide Wash Recalled for Subpotency Issues

    Monarch PCM, LLC is recalling Sodium Sulfacetamide 10% Wash due to subpotency, meaning some bottles contain insufficient active ingredient or preservative levels.

    Product
    Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2486-2021·2021-09-29

    Microbiologics SARS-CoV-2 Process Control Pellets Recalled for Product Specification Issue

    Microbiologics Inc is recalling 218 units of SARS-CoV-2 process control pellets (catalog HE0062S) used to validate diagnostic tests. The FDA Class II recall involves product composition regarding RNA transcript content.

    Product
    SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0993-2021·2021-09-29

    Fleischmann's Compressed Fresh Yeast Recall Due to Temperature Control

    Sysco Atlanta is recalling Fleischmann's Yeast Compressed Fresh in 24/1 lb packages because the product was not stored at appropriate temperatures, creating potential food safety risk.

    Product
    FLEISCHMANN'S YEAST COMPRESSED FRESH ESL 24/1lbs Paper/Foil overwrap
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1003-2021·2021-09-29

    TULKOFF Ginger Puree Recalled for Improper Temperature Storage

    Sysco Atlanta is recalling TULKOFF Ginger Puree because the product was not held at appropriate temperatures, making it potentially unsafe to consume.

    Product
    TULKOFF Ginger Puree 6/32oz Tubs UPC 1 00 70607 50015 6 Tulkoff Food Products, Inc. Baltimore, MD 21224 KEEP REFRIGERATED
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0829-2021·2021-09-29

    Zonisamide 100 mg Capsules Recalled Due to Quality Control Gaps

    Direct Rx is recalling Zonisamide 100 mg Capsules (30-count bottles, Lot #17JU2118, expiration 5/31/23) distributed in Florida due to gaps in the quality system in the Quality Control microbiology laboratory.

    Product
    Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0807-2021·2021-09-29

    Carbamazepine 200mg Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Carbamazepine 200mg tablets (Lot R01562, expiring 10/2022) distributed in North Carolina because they failed to meet required dissolution specifications, which may affect the drug's effectiveness.

    Product
    CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0998-2021·2021-09-29

    Ken's Steakhouse Asian Sesame Dressing Recalled for Temperature Control

    Sysco Atlanta is recalling Ken's Steakhouse Asian Sesame Dressing after the product was not held at appropriate temperatures. The improper storage conditions could make the food unsafe to consume.

    Product
    KEN'S STEAKHOUSE DRESSING ASIAN SESAME DRESSING 4/1gallon Plastic container Ken's Foods Inc Marlborough, MA 01752 MUST BE REFRIGERATED
    Category
    Food
    Distribution
    3 states