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.

3001–3025 of 3531

  • ModerateFDA (Drugs)·D-0356-2022·2022-01-12

    CVS Allergy Relief Fexofenadine Tablets Recalled for Impurity Specifications

    Perrigo Company is recalling CVS Allergy Relief Fexofenadine Hydrochloride 180 mg tablets due to an out-of-specification impurity result found during stability testing. The recall affects one lot distributed nationwide.

    Product
    CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0454-2022·2022-01-12

    iontoPATCH On-the-Go transdermal patch has incorrect dosage information on pouch

    Tapemark's iontoPATCH On-the-Go patches contain incorrect dosage information printed on the pouch label, though the primary carton label is correct. Approximately 5,141 cartons were distributed nationwide.

    Product
    iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0349-2022·2022-01-12

    TopCare Allergy Relief Fexofenadine tablets recalled for impurity specification failure

    Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 60mg tablets (12-count bottles, Lot #0LE2178) distributed nationwide due to an out-of-specification impurity result found during stability testing.

    Product
    TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0340-2022·2022-01-12

    H.E.B Allergy Relief Fexofenadine Tablets Recalled for Failed Impurity Specifications

    H.E.B Allergy Relief fexofenadine hydrochloride tablets (180mg) are being recalled nationwide due to out-of-specification results for impurity A found during stability testing. The affected product is available in 15, 30, and 45 count bottles.

    Product
    H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Ma
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0338-2022·2022-01-12

    Health Mart Fexofenadine Hydrochloride 180mg Tablets Recall

    Perrigo Company is recalling Health Mart Fexofenadine Hydrochloride 180mg antihistamine tablets due to failed impurity specifications detected during stability testing. The recall affects approximately 6,960 containers distributed nationwide.

    Product
    Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0351-2022·2022-01-12

    Up&Up Allergy Relief 180mg Tablets Recalled for Failed Impurity Specification

    Perrigo Company PLC is recalling up&up allergy relief fexofenadine hydrochloride 180mg tablets distributed nationwide because stability testing found impurity A exceeded specifications. The affected products are 15-count and 30-count bottles with specific lot numbers and expiration dates.

    Product
    up&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihistamine, packaged as a) 15 count bottle, NDC 11673-571-22 UPC 3 70030 62303 7; b) 30 count bottle, NDC 11673-571-39 UPC 3 70030 62301 3; Distributed by Target Corp., Mpls., MN 55403, Made in the Czech Re
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0326-2022·2022-01-12

    Gatifloxacin Ophthalmic Solution Recall Due to Failed Stability Testing

    Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% because water loss test results fell out of specification, which could affect the drug's assay content and concentration.

    Product
    Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0361-2022·2022-01-12

    Diet Snapple Peach Tea Recall Due to Undeclared Sugar Content

    Keurig Dr Pepper is recalling Diet Snapple Peach Tea 16 oz bottles with expiration date February 5, 2022, because some units labeled as diet and zero sugar may contain sugar due to a production error.

    Product
    Diet Snapple Tea Peach Tea 16 oz. packaged in PET bottle. Expiration Date: February 5, 2022. UPC single bottles: 0 7618300314 5. UPC 12 Pack 0 7618300813 3.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0343-2022·2022-01-12

    Meijer Fexofenadine Hydrochloride Allergy Relief Tablets Recalled

    Meijer allergy relief tablets containing fexofenadine hydrochloride are being recalled nationwide due to out-of-specification impurity results found during stability testing.

    Product
    Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 41250-060-22 UPC 7 60236 18716 5; b) 30 count bottle, NDC 41250-060-39, UPC 7 60236 18717 2; c) 45 count bottle, NDC 41250-060-95, UPC 7 60236 18732 5; Made
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0353-2022·2022-01-12

    Wal-Fex Fexofenadine Tablets Recalled for Impurity Specifications

    Perrigo Company is recalling Wal-Fex Fexofenadine Hydrochloride 60mg tablets due to out-of-specification impurity levels detected during stability testing. The recall affects 4,536 containers distributed nationwide.

    Product
    Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0332-2022·2022-01-12

    Fexofenadine Hydrochloride Tablets Recall for Failed Impurity Specifications

    Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets, 60 mg, 100-count bottles, due to out-of-specification impurity levels detected during stability testing.

    Product
    basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7425-78 UPC 3 70030 14536 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0334-2022·2022-01-12

    CAREONE Allergy Relief 180 mg Tablets Recalled for Failed Impurities Specifications

    Perrigo Company PLC is recalling CAREONE Allergy Relief (Fexofenadine HCL) 180 mg tablets nationwide because stability testing found impurity A out of specification.

    Product
    CAREONE ALLERGY RELIEF — CAREONE ALLERGY RELIEF (FEXOFENADINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0327-2022·2022-01-12

    Pain Aid ESF Bulk Tablets Recall Due to Manufacturing Process Failures

    ULTRAtab Laboratories is recalling Pain Aid ESF bulk tablets due to failed stability test results and inadequate laboratory investigations, which represent deviations from manufacturing standards.

    Product
    PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0359-2022·2022-01-12

    Cefixime Capsules 400 mg Recalled for Failed Impurities and Degradation

    Ascend Laboratories recalls Cefixime 400 mg capsules due to failed impurities and degradation specifications. The affected 42,698 bottles were distributed nationwide.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0347-2022·2022-01-12

    Rite Aid Allergy Relief Fexofenadine Tablets Recalled for Impurity

    Rite Aid Allergy Relief Fexofenadine Hydrochloride 60mg tablets are being recalled due to failed impurity specifications detected during stability testing. The affected product was distributed nationwide.

    Product
    Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0345-2022·2022-01-12

    Perrigo Fexofenadine Hydrochloride 180mg tablets recalled for impurity

    Perrigo Company PLC is recalling Fexofenadine Hydrochloride 180mg antihistamine tablets due to an out-of-specification impurity result detected during stability testing. The recall affects approximately 89,664 containers distributed nationwide.

    Product
    Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0361-2022·2022-01-12

    Pregabalin Capsules Recalled for Out-of-Specification Manufacturing Defects

    Sun Pharmaceutical Industries is recalling Pregabalin 50 mg capsules due to out-of-specification results in particle size distribution and bulk density of the active pharmaceutical ingredient.

    Product
    PREGABALIN — PREGABALIN (PREGABALIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0452-2022·2022-01-12

    Biomeme SARS-CoV-2 Test Instructions Recall: Incorrect Buffer Shelf-Life

    Biomeme, Inc. is recalling instructions for the SARS-CoV-2 Real Time RT-PCR Test because shelf-life guidance for resuspended RPC Buffer is incorrect. Instructions specify one week stability, but the buffer is only stable for two days at room temperature.

    Product
    Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Drugs)·D-0350-2022·2022-01-12

    TopCare Allergy Relief Fexofenadine tablets recalled for impurity specifications

    Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 180mg tablets in multiple pack sizes due to failed impurity specifications during stability testing. The affected lots were distributed nationwide.

    Product
    TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0348-2022·2022-01-12

    Rite Aid Allergy Relief Fexofenadine tablets recalled for impurity

    Perrigo Company PLC is recalling Rite Aid Allergy Relief Fexofenadine Hydrochloride 180mg tablets nationwide due to failed impurity specifications. An out-of-specification result for impurity A was found during stability testing.

    Product
    Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0328-2022·2022-01-12

    EQUALINE Fexofenadine Hydrochloride Tablets Recalled for Failed Impurity Testing

    Perrigo Company is recalling EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, due to impurity A exceeding specification limits during stability testing. The recalled products were distributed nationwide.

    Product
    EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0344-2022·2022-01-12

    Allergyrelief Fexofenadine Tablets Recalled for Impurity Specification Failure

    Perrigo Company is recalling allergyrelief Fexofenadine Hydrochloride 24HR tablets due to an out-of-specification result for impurity A detected during stability testing.

    Product
    allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 56062-571-22 UPC 0 41415 38973 1; b) 45 count bottle, NDC 56062-571-95 UPC 0 41415 38773 7; Distributed by PubliX SUpermarket Inc 3300 Publix Corporate Parkway Lak
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0296-2022·2022-01-05

    Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

    Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to superpotency. The affected lot was distributed nationwide.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0433-2022·2022-01-05

    VIDAS LH diagnostic test substrate error causes delayed results

    bioMerieux VIDAS LH test kits (lot 1008848600) are affected by a substrate error that prevents test execution, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS LH, REF 30406-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0297-2022·2022-01-05

    Betamethasone Dipropionate Lotion recalled for failed stability test

    Teligent Pharma is recalling Betamethasone Dipropionate Lotion USP 0.05% (Augmented) due to failure to meet specification for the Active Pharmaceutical Ingredient particle test during routine stability testing.

    Product
    Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
    Category
    Drug
    Distribution
    Distributed nationwide