The Recall Desk

Hazard

Cgmp Deviation recalls

1,552 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,552
Critical
1
Severe
283
Most recent
2026-09-02

Of the 1,552 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 283 (18%) are Severe.

About this hazard tag

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

476–500 of 1552

  • ModerateFDA (Drugs)·D-1438-2022·2022-08-31

    Carmex Lip Balm Products Recalled Due to Improper Storage Temperatures

    Family Dollar Stores is recalling Carmex lip balm products (three SKUs) distributed from April 30 to June 10, 2022, due to CGMP deviations involving improper storage temperature conditions.

    Product
    CARMEX DAILY CARE CHERRY SPF 15 0.35 OZ SKU 901842 CARMEX LIP BALM JAR 0.25OZ SKU 903284 CARMEX STRWBRRY STCK W SPF 15 0.15OZ SKU 905760 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1460-2022·2022-08-31

    Mucinex SE Max Strength recalled for improper storage conditions

    Family Dollar Stores is recalling Mucinex SE Max Strength 7CT distributed from April through June 2022 due to CGMP deviations involving improper storage temperature.

    Product
    MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1456-2022·2022-08-31

    OTC Cough Medications Recalled for Improper Storage Temperature

    Family Dollar is recalling four OTC cough and mucus relief medications that were stored outside appropriate temperature conditions.

    Product
    REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC MUCUS RLF DM MAX STNGTH CHRY 6FL OZ SKU 999559 VICKS JARABE COUGH CONGESTION 8FLOZ SKU 998933 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1439-2022·2022-08-31

    MIDOL and Related OTC Menstrual Relief Products Recalled for Temperature Storage Deviation

    Family Dollar Stores recalled MIDOL COMPLETE, QP MENSTRUAL RELIEF, and QP PMS FORMULA caplets distributed April–June 2022 due to CGMP deviations from improper storage temperature.

    Product
    MIDOL COMPLETE CAPLET 16 CT SKU 913028 QP MENSTRUAL RELIEF COMPLETE CAPLET 16CT SKU 999982 QP PMS FORMULA CAPLET 32 CT SKU 913232 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1392-2022·2022-08-31

    Pain Reliever Caplets Recalled for Improper Storage Temperature

    Over-the-counter pain reliever caplet products from Family Dollar stores are being recalled because they were stored outside proper temperature conditions.

    Product
    READY IN CASE PAIN RELIEVER PM CAPLET 100 CT SKU 902381 GOOD SENSE PAIN RELIEVER APAP 500MG CAPLET 250CT SKU 902332 READY IN CASE PM PAIN RELIEVER CAPLET 50 CT SKU 913982 GOOD SENSE PAIN RELIEVER APAP ES 500 CT SKU 999029 GOOD SENSE PAIN RELIEVER CAPLET 100 CT SKU 913890
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1453-2022·2022-08-31

    Robitussin and Delsym Cough Medications Recalled for Storage Temperature Violations

    Family Dollar Stores is recalling Robitussin Cough N Chest Congestion (4 FL OZ, SKU 919471) and Delsym Orange (3 FL OZ, SKU 901880) because these medications were stored outside proper temperature conditions.

    Product
    ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL OZ SKU 901880 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1389-2022·2022-08-31

    Lidocaine arthritis topical product recalled due to improper storage

    Family Dollar Stores is recalling Lidocaine Arthritis and Sport wintergreen liniment (16 fl oz, SKU 902929) distributed nationwide April 30–June 10, 2022, due to improper storage temperature conditions.

    Product
    LIDOCAINE ARTHRITIS AND SPORT WNTGRN 16 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1436-2022·2022-08-31

    Lidocaine Cream Products Recalled for Improper Storage Conditions at Family Dollar

    Family Dollar is recalling Aspercreme with Lidocaine Creme (SKU 999852) and Icy Hot Lidocaine Cream (SKU 999853) distributed April 30 through June 10, 2022 nationwide due to improper storage temperature conditions.

    Product
    ASPERCREME WITH LIDOCAINE CREME 1.75 OZ SKU 999852 ICY HOT LIDOCAINE CREAM 1.75 OZ SKU 999853 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1445-2022·2022-08-31

    Nicorette Gum Recalled Due to Improper Storage Temperature Conditions

    Family Dollar Stores is recalling NICORETTE GUM WHITE ICE MINT 4 MG distributed from April 30 through June 10, 2022. The product was held outside appropriate storage temperature conditions.

    Product
    NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1373-2022·2022-08-31

    Multiple ibuprofen products recalled for improper storage temperature

    Family Dollar is recalling multiple ibuprofen products, including MOTRIN and GOOD SENSE brands, due to improper storage temperature conditions at distribution facilities from April through June 2022.

    Product
    MOTRIN IB CAPLETS 24CT SKU999394; GOOD SENSE IBUPROFEN 200MG TABLETS 24CT SKU 900556;GOOD SENSE IBUPROFEN 200MG CAPLET 50 CT SKU 902333 MOTRIN CHILDREN'S BUBBLEGUM 4 FL OZ SKU 903048 GOOD SENSE IBUPROFEN REGULAR SOFTGELS 160CT SKU 999373 GOOD SENSE IBUPROFEN 200 MG CAPLE
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1416-2022·2022-08-31

    Mylanta Max Strength Classic flavor antacid recalled for improper storage conditions

    Mylanta Max Strength Classic flavor antacid (12 fl oz, SKU 999844) has been recalled due to improper storage temperature conditions. The product was distributed nationwide to Family Dollar Stores from April 30 to June 10, 2022.

    Product
    MYLANTA MAX STRENGTH CLASSIC FLVR 12 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1356-2022·2022-08-24

    Avant Foaming Hand Sanitizer recalled due to manufacturing process deviation

    Aire-Master of America is recalling Avant Foaming Hand Sanitizer due to a manufacturing process deviation where the deionized water system lacked proper microbial controls during production.

    Product
    Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1359-2022·2022-08-24

    Foaming Hand Sanitizer Recalled for Water System Manufacturing Deficiency

    Protect U Guard Foaming Hand Sanitizer is being recalled because it was manufactured with deionized water from a system lacking proper microbial controls. The affected product was distributed in Florida, Illinois, Iowa, and New Jersey.

    Product
    Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1346-2022·2022-08-24

    Injectable Bupivacaine Recalled Due to Manufacturing Cross-Contamination Risk

    Nephron Sterile Compounding Center is recalling 2,030 bags of injectable bupivacaine due to potential cross-contamination from manufacturing process defects. No illnesses have been reported.

    Product
    PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1343-2022·2022-08-24

    Rifampin Capsules Recalled Due to Manufacturing Control Deviation

    Lupin Pharmaceuticals is recalling Rifampin 150 mg capsules (lot #A200170) nationwide due to a Current Good Manufacturing Practice deviation with an out-of-specification impurity detected during manufacturing.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1318-2022·2022-08-17

    Earwax Removal Aid Debrox Recalled Nationwide for Improper Storage Conditions

    Debrox earwax removal aid is recalled nationwide because 131 boxes of the product were stored outside label-specified conditions. Consumers should discontinue use and consult a healthcare provider if needed.

    Product
    DEBROX — DEBROX (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1322-2022·2022-08-17

    FDA Recalls A&D Original Ointment due to improper storage conditions

    A&D Original Ointment 16 oz jars are being recalled nationwide because products were stored outside manufacturer specifications. The recall affects all NDC 11523-0096-3 units distributed in the USA.

    Product
    A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1316-2022·2022-08-17

    Eye Drops Recalled for Improper Storage Outside Specifications

    SYSTANE BALANCE lubricant eye drops (12 boxes, nationwide) are being recalled because they were stored outside the manufacturer's label specifications. The FDA classified this as a Class II recall.

    Product
    SYSTANE BALANCE — SYSTANE BALANCE (PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1324-2022·2022-08-17

    Asthmanefrin Racephinephrine Inhalation Solution Recalled Due to Improper Storage

    Asthmanefrin Racephinephrine Inhalation Solution is being recalled because batches were stored outside the conditions specified on the drug label. The recall affects products distributed nationwide.

    Product
    Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1180-2022·2022-07-13

    Prescription Drug Recall: Enalapril Maleate Due to Manufacturing Deviations

    Golden State Medical Supply Inc. is recalling 1,424 bottles of Enalapril Maleate 20 mg tablets due to Current Good Manufacturing Practice deviations. The affected lot numbers have expiration dates ranging from March 2022 to December 2022.

    Product
    ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1177-2022·2022-07-13

    Prescription drug Enalapril Maleate recalled for manufacturing deviations

    Golden State Medical Supply Inc. is recalling Enalapril Maleate 2.5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. Approximately 1,471 bottles were distributed nationwide.

    Product
    ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1178-2022·2022-07-13

    Enalapril Maleate Tablets Recalled Due to Manufacturing Practice Deviations

    Golden State Medical Supply Inc. is recalling Enalapril Maleate Tablets due to manufacturing practice deviations. The voluntary recall involves 9,058 units distributed nationwide.

    Product
    ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1164-2022·2022-07-06

    FDA Recalls Losartan-Hydrochlorothiazide Tablets for Manufacturing Quality Deviations

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets (100 mg/25 mg) due to CGMP deviations and azido impurity levels exceeding acceptable limits. The affected lot is BLM2114A (expiration 07/2023) distributed nationwide.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1171-2022·2022-07-06

    Desmopressin Acetate Tablets recalled for manufacturing process deviations

    Glenmark Pharmaceuticals voluntarily recalls 36 bottles of Desmopressin Acetate Tablets (0.2 mg) due to manufacturing process deviations. The recall affected one distributor in Texas.

    Product
    Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1139-2022·2022-06-22

    Homeopathic Tuberculinum Drug Recalled for Manufacturing Practice Deviations

    Washington Homeopathic Products is recalling Tuberculinum homeopathic drug in multiple potencies due to manufacturing practice deviations. The voluntary recall affects product distributed nationwide.

    Product
    Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide