The Recall Desk

Hazard

Cgmp Deviation recalls

1,563 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,563
Critical
1
Severe
288
Most recent
2026-09-09

Of the 1,563 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 288 (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 1563

  • ModerateFDA (Drugs)·D-1511-2022·2022-09-21

    OTC Magnesium Citrate Laxative Recalled for Manufacturing Process Deviations

    Magnesium citrate saline laxative products branded as CITROMA and multiple retail equivalents are subject to a Class II recall due to manufacturing process deviations. The voluntary recall affects millions of bottles distributed nationwide and internationally.

    Product
    CITROMA — CITROMA (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1512-2022·2022-09-21

    FDA Recalls Citroma Magnesium Citrate Laxative for Manufacturing Deviations

    Vi-Jon is recalling Citroma magnesium citrate oral laxative due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed nationwide and internationally.

    Product
    CITROMA — CITROMA (MAGNESIUM CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1487-2022·2022-09-14

    Calcium Carbonate Oral Suspension Recalled Due to Manufacturing Control Deviations

    Plastikon Healthcare recalls 49,280 cups of Calcium Carbonate Oral Suspension (1250 mg/5 mL) distributed nationwide due to manufacturing process control failures during production.

    Product
    CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1490-2022·2022-09-14

    Guaifenesin and dextromethorphan liquid medication recalled for manufacturing control issues

    Plastikon Healthcare LLC is recalling guaifenesin and dextromethorphan liquid medication (280,500 cups) distributed nationwide due to manufacturing control deviations in production.

    Product
    GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152. NDC 0904-6844-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1391-2022·2022-08-31

    FDA Recalls BC and Goody's Powders Due to Improper Storage Conditions

    Family Dollar Stores is recalling BC Powder and Goody's Powder products due to improper storage temperature conditions. The affected products were distributed nationwide from April 30 through June 10, 2022.

    Product
    BC POWDER 50 CT SKU 901588 BC POWDER 18 CT SKU 913228 GOODYS POWDER 50 CT SKU 901589 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1401-2022·2022-08-31

    Jet Alert Tablets Recalled for Improper Storage Temperature Conditions

    Jet Alert stimulant tablets distributed nationwide from April to June 2022 are being recalled due to improper storage temperature conditions that may affect product safety and efficacy.

    Product
    JET ALERT TABLET 30 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1387-2022·2022-08-31

    Topical ointment recall due to improper storage temperature conditions

    Family Dollar Stores is recalling AD PREV OINT ORIG 4 OZ due to improper storage conditions that may affect product quality. Products distributed nationwide from April 30 through June 10, 2022 are affected.

    Product
    AD PREV OINT ORIG 4 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1408-2022·2022-08-31

    Witch hazel product recalled for improper storage temperature conditions

    Witch hazel product distributed to Family Dollar Stores from April through June 2022 was stored at improper temperatures. The FDA issued a Class II recall due to manufacturing and quality control (CGMP) deviations.

    Product
    TN DICKINSON WITCH HAZEL 16 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1367-2022·2022-08-31

    Multiple Toothpaste and Dental Care Products Recalled for Improper Storage

    Family Dollar Stores is recalling multiple toothpaste and dental care products that were stored outside appropriate temperature conditions, distributed April 30–June 10, 2022.

    Product
    COLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ 3PK SKU 900734 SENSODYNE REPAIR AND PROTCT WHITNG 3.4 OZ SKU 901003 COLGATE BSPW PASTE BRISK MINT 6 OZ 2PK SKU 901658 COLGATE MAX FRESH COOL MINT 6OZ 2PK SKU 901785 COLGATE BSPW PASTE 6 OZ 3PK SKU 9
    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-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-1433-2022·2022-08-31

    Acne Treatment Products Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling two acne treatment products due to storage condition deviations. The products were held outside appropriate temperature ranges.

    Product
    ACNE FREE ADAPALENE GL ACN TRTMT 0.5 OZ SKU 2096518 ACNE FREE TRMINTR 10 SPOT TRTMT 1 OZ SKU 2096507 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-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-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-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-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
  • 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-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-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
  • 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-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
  • 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