The Recall Desk

Hazard

Manufacturing Deviation recalls

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

What the numbers show

Total
296
Critical
0
Severe
7
Most recent
2026-09-09

Of the 296 manufacturing deviation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (2%) 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 manufacturing 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.

251–275 of 296

  • ModerateFDA (Drugs)·D-0477-2022·2022-02-09

    Cetafen acetaminophen tablets recalled for manufacturing deviations

    Ultra Seal Corporation is recalling Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets in 2-count packets due to current good manufacturing practice (cGMP) deviations. The recall affects 915,770 packets distributed nationwide.

    Product
    Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0431-2022·2022-02-02

    FDA Recalls CSF Otic Insufflation Capsule for CGMP Deviations

    Edge Pharma, LLC is recalling 1055 bottles of CSF Otic Insufflation Capsule containing Sulfacetamide Sodium, Ciprofloxacin, and Amphotericin B nationwide due to CGMP manufacturing deviations.

    Product
    CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Otic Use with Insufflator, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1633-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0432-2022·2022-02-02

    CSF-HC Otic Powder Drug Recalled for Manufacturing Deviations

    Edge Pharma, LLC is recalling CSF-HC Otic Insufflation Capsule nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 440 cartons of this antibiotic and steroid combination powder.

    Product
    CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0387-2022·2022-01-26

    Lexette Topical Foam Recall Due to Dispensing Defects

    Mayne Pharma is recalling Lexette (halobetasol propionate) Topical Foam 0.05% due to manufacturing defects that cause the product to either not dispense or dispense liquid instead of foam. The recall affects 17,113 canisters distributed nationwide.

    Product
    Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0236-2022·2021-11-24

    LOTRIMIN AF Miconazole Nitrate Powder Spray Recalled for Benzene Contamination

    Bayer is recalling LOTRIMIN AF Deodorant Powder Spray due to potential benzene contamination from manufacturing deviations at a facility where other lots were found contaminated. The recall affects 2,817,468 cans distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0240-2022·2021-11-24

    Lotrimin Daily Prevention Deo Spray Recalled for Benzene Contamination Risk

    Bayer Healthcare Pharmaceuticals is recalling Lotrimin Daily Prevention Deo (Tolnaftate) spray due to potential benzene contamination from manufacturing facility cGMP deviations. The product was distributed nationwide and internationally.

    Product
    LOTRIMIN DAILY PREVENTION DEO — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0086-2022·2021-11-10

    Lupin Irbesartan Tablets Recalled for Impurity Contamination

    Lupin Pharmaceuticals is recalling Irbesartan 75 mg tablets due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient. The recall affects 51,144 bottles distributed nationwide.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0015-2022·2021-10-27

    Coppertone Pure & Simple 50 Sunscreen Spray Recall for cGMP Deviations

    Beiersdorf Inc. is recalling Coppertone Pure & Simple 50 Sunscreen Spray due to manufacturing practice deviations. Approximately 36,660 cans were distributed nationwide.

    Product
    Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0839-2021·2021-10-06

    Neutrogena Ultra Sheer Sunscreen Recalled for cGMP Deviations

    Johnson & Johnson Consumer is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 100+ nationwide due to manufacturing deviations. Approximately 3.98 million cans are affected.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (15%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08858, UPC 0 86800 10041 6
    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-0854-2021·2021-10-06

    Valproic Acid Oral Solution Recalled for Microbial Contamination

    American Health Packaging is recalling Valproic Acid Oral Solution due to potential microbial contamination in liquid sugar batches used during manufacturing. The affected product was distributed nationwide.

    Product
    Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0825-2021·2021-09-29

    Zonisamide Capsules Recalled for Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Zonisamide Capsules 50 mg nationwide due to manufacturing deviations. The recall affects approximately 15,936 bottles across multiple lots with expiration dates in May 2022.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0816-2021·2021-09-29

    Valproic Acid Oral Solution recalled for microbial contamination

    Morton Grove Pharmaceuticals is recalling Valproic Acid Oral Solution (250 mg/5 mL) due to potential microbial contamination in liquid sugar batches used during manufacturing.

    Product
    Valproic Acid Oral Solution USP, (250 mg/5 mL), 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: 60432-621-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0810-2021·2021-09-29

    Chantix Varenicline Tablets Recalled for N-Nitroso Impurity

    Pfizer is recalling specific lots of Chantix (varenicline) 1 mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The affected lots were distributed nationwide.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0778-2021·2021-09-08

    Hand Sanitizer Gel Recalled Due to Methanol Contamination Risk

    Global Sanitizers LLC is recalling MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel (70% ethyl alcohol) due to manufacturing deviations. Products were made under the same conditions as a lot found to contain methanol.

    Product
    MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0783-2021·2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel Recalled for Manufacturing Deviations

    Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (70% ethyl alcohol, 8 fl oz bottles) distributed nationwide due to manufacturing deviations under conditions that produced a methanol-contaminated product lot.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200. Distributed by SBL Brands, LLC Las Vegas, NV 89119 UPC: 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0774-2021·2021-09-08

    Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination

    Teva Pharmaceuticals is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial counts in an ingredient batch. The product was distributed nationwide.

    Product
    Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0700-2021·2021-08-11

    Pfizer Chantix Tablets Recalled for N-Nitroso-Varenicline Impurity

    Pfizer is recalling approximately 350,985 cartons of Chantix (varenicline tartrate) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects multiple lot numbers with expiration dates ranging from September 2021 to January 2023.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0658-2021·2021-07-21

    Durisan Antimicrobial Hand Sanitizer Recalled for Manufacturing Deviations

    Sanit Technologies, LLC is recalling multiple lots of Durisan Antimicrobial Solutions hand sanitizer due to manufacturing deviations. The affected products were manufactured under the same conditions as contaminated lots.

    Product
    Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 0061
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0665-2021·2021-06-23

    BTREX PLUS Dietary Supplement Recalled for Damaged Tablets

    Lopez Gonzalez Santana Corporation is recalling BTREX PLUS Dietary Supplement (100 caplets, UPC 05380930801, Lot #30636, Exp. 01/2022) due to the presence of damaged tablets resulting from manufacturing deviations.

    Product
    BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1237-2020·2020-04-22

    Aurobindo Recalls Oxycodone and Acetaminophen Tablets Due to Water Leakage

    Aurobindo Pharma USA Inc. is recalling specific lots of Oxycodone and Acetaminophen tablets because they were manufactured in an area with observed water leakage.

    Product
    OXYCODONE AND ACETAMINOPHEN — OXYCODONE AND ACETAMINOPHEN (OXYCODONE AND ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1231-2020·2020-04-22

    Aurobindo Recalls Acetaminophen and Codeine Tablets Due to Water Leakage

    Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.

    Product
    ACETAMINOPHEN AND CODEINE PHOSPHATE — ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1230-2020·2020-04-22

    Aurobindo Recalls Acetaminophen and Codeine Tablets Due to Manufacturing Deviations

    Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.

    Product
    ACETAMINOPHEN AND CODEINE PHOSPHATE — ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1051-2020·2020-03-25

    Breckenridge Recalls Solifenacin Succinate Tablets Due to Manufacturing Deviations

    Breckenridge Pharmaceutical is recalling specific lots of Solifenacin Succinate Tablets because manufacturing deviations may have resulted in the production of Solifenacin Tartrate.

    Product
    Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pith
    Category
    Drug
    Distribution
    Distributed nationwide