The Recall Desk

Hazard

Reduced Efficacy recalls

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

What the numbers show

Total
63
Critical
0
Severe
5
Most recent
2026-08-19

Of the 63 reduced efficacy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (8%) 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 reduced efficacy 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.

26–50 of 63

  • ModerateFDA (Drugs)·D-1403-2022·2022-08-31

    MY CHOICE Levonorgestrel Tablets Recalled for Storage Temperature Deviation

    Family Dollar Stores is recalling MY CHOICE Levonorgestrel Tablets due to storage temperature deviations that may affect product efficacy. The tablets were distributed nationwide between April 30 and June 10, 2022.

    Product
    MY CHOICE LEVONORGESTREL TABLET distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1026-2022·2022-06-15

    Apraclonidine ophthalmic solution recalled for temperature-abuse manufacturing defect

    McKesson Medical-Surgical is recalling 21 bottles of Apraclonidine 0.5% ophthalmic solution due to cGMP deviations involving temperature abuse during manufacturing. The temperature exposure may reduce drug efficacy.

    Product
    APRACLONIDINE — APRACLONIDINE (APRACLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1025-2022·2022-06-15

    Amoxicillin capsules recalled due to temperature exposure during manufacturing

    McKesson Medical-Surgical is recalling Amoxicillin 500mg capsules distributed nationwide due to temperature abuse during manufacturing that may compromise product potency and effectiveness.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1075-2022·2022-06-15

    FDA Recalls Mupirocin Ointment Due to Temperature Control Deviations

    Mupirocin Ointment distributed nationwide is being recalled due to temperature abuse violations during manufacturing. Consumers with affected supplies should contact their pharmacy or healthcare provider for guidance.

    Product
    MUPIROCIN — MUPIROCIN (MUPIROCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0979-2022·2022-06-08

    Hand Sanitizer Recalled for Improper Temperature Storage Conditions

    Family Dollar Stores is recalling Luxury Hygiene Hand Sanitizer due to storage outside of labeled temperature requirements, which may affect product efficacy.

    Product
    Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0975-2022·2022-06-08

    Family Dollar AMBI Skincare Sunscreen Recalled for Improper Storage

    Family Dollar is recalling an AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer (SPF 30) for improper storage. The product may have reduced efficacy.

    Product
    Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer With Broad Spectrum SPF 30 Sunscreen, Net Wt. 1.7 FL. OZ. (50 mL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0718-2022·2022-03-30

    Sermorelin Acetate Injectable Recalled for Sub-Potent Strength

    Olympia Compounding Pharmacy is recalling Sermorelin Acetate 9 mg multi-dose vials nationwide due to sub-potency. The affected lots do not contain the full intended strength of the medication.

    Product
    Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0646-2022·2022-03-02

    Premium Nature Instant Hand Sanitizer Recalled for Subpotent Ethanol Content

    Premium Nature Instant Hand Sanitizer is being recalled nationwide because some bottles were found to contain subpotent levels of ethanol. The FDA identified the issue during analysis of multiple bottle sizes.

    Product
    Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0451-2022·2022-02-02

    Metoprolol Succinate ER Tablets Recall for Failed Dissolution

    American Health Packaging is recalling Metoprolol Succinate Extended-Release Tablets 50 mg nationwide due to failed dissolution specifications. The affected lots may not release the medication properly, potentially reducing its effectiveness.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0384-2022·2022-01-26

    QC Quality Choice Fexofenadine/Pseudoephedrine Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling QC Quality Choice Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg Extended-Release Tablets nationwide due to failed dissolution specifications that may reduce the medication's effectiveness.

    Product
    QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0382-2022·2022-01-26

    Dr. Reddy's Fexofenadine/Pseudoephedrine Tablets Fail Dissolution Specification

    Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets because the tablets failed to meet dissolution specifications, which may affect the drug's effectiveness.

    Product
    Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0271-2022·2021-12-15

    Antihistamine and Decongestant Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets distributed by Rugby Laboratories due to failed dissolution specifications. Affected lot AC2103329D (Exp 1/2023) was distributed nationwide in 2,184 cartons.

    Product
    Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0274-2022·2021-12-15

    Walmart Allergy Relief D Extended-Release Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Walmart brand Allergy Relief D extended-release tablets (Lot #AC2103329B) nationwide because the tablets failed to meet dissolution specifications, which may affect medication effectiveness.

    Product
    Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0269-2022·2021-12-15

    OTC Allergy and Congestion Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling 5,016 cartons of Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg Extended Release Tablets nationwide due to failed dissolution specifications. Affected lot is AC2103329F with expiration 1/2023.

    Product
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0273-2022·2021-12-15

    CVS Allergy Relief D Extended-Release Tablets Recall

    CVS Allergy Relief D extended-release tablets (Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg) are being recalled because they failed dissolution specifications, meaning the tablets may not release the medication properly.

    Product
    Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0272-2022·2021-12-15

    Fexofenadine and Pseudoephedrine allergy relief tablets recalled for failed dissolution

    Dr. Reddy's Laboratories is recalling a 12 HR Allergy & Congestion Relief product distributed nationwide because the tablets failed to meet dissolution specifications, which may affect drug effectiveness.

    Product
    12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0233-2022·2021-11-24

    Flocinolone Acetonide 0.01% Topical Oil Recalled for Subpotency

    Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil due to an out-of-specification assay result indicating the drug is subpotent and may not deliver the intended therapeutic dose.

    Product
    Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0023-2022·2021-10-27

    AirDuo Digihaler 55/14 Inhalation Powder Recalled for Subpotent Dose

    Teva Pharmaceuticals is recalling AirDuo Digihaler 55/14 inhalation powder due to subpotent emitted dose of salmeterol. Approximately 1,978 inhalers distributed nationwide may deliver less medication than labeled.

    Product
    AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0027-2022·2021-10-27

    Lupin Imipramine Pamoate Capsules Recalled for Failed Dissolution Test

    Lupin Pharmaceuticals is recalling approximately 1,902 bottles of Imipramine Pamoate Capsules 125 mg due to out-of-specification results in dissolution testing at the 9-month stability checkpoint.

    Product
    IMIPRAMINE PAMOATE — IMIPRAMINE PAMOATE (IMIPRAMINE PAMOATE)
    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 (Drugs)·D-0851-2021·2021-10-06

    Lyrica CR 330 mg Tablets Recalled for Failed Dissolution

    Viatris is recalling Lyrica CR (pregabalin) 330 mg extended-release tablets nationwide due to failed dissolution specifications that may reduce drug effectiveness.

    Product
    Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Drugs)·D-0764-2021·2021-09-01

    PDI Duo-Swab Povidone-Iodine Cleansing Swabstick Recalled for Subpotency

    Professional Disposables International is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotency—the active ingredient is below the specified strength, which may reduce effectiveness for skin antisepsis.

    Product
    PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)0
    Category
    Drug
    Distribution
    Distributed nationwide