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.

201–225 of 296

  • HighFDA (Drugs)·D-0887-2022·2022-06-01

    Losartan HCTZ tablets recalled for manufacturing impurity levels above acceptable limits

    RemedyRepack Inc. is recalling Losartan HCTZ 100/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recall affects bottles distributed to Florida, South Carolina, and Virginia.

    Product
    Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0891-2022·2022-06-01

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Elevated Azido Impurity

    Preferred Pharmaceuticals recalls Losartan Potassium & HCTZ Tablets (50mg/12.5mg) in Florida and California due to elevated azido impurity levels above acceptable manufacturing limits.

    Product
    Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0872-2022·2022-05-25

    Accupril tablets recalled by Pfizer for nitrosamine impurity

    Pfizer is recalling 2,079 bottles of Accupril (Quinapril HCl) 10 mg tablets due to N-nitrosoquinapril exceeding acceptable limits. The affected lot was distributed nationwide and in Puerto Rico.

    Product
    Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1060-2022·2022-05-18

    First Aid Kits and Cabinets Recalled for Manufacturing Deviations

    Certified Safety Mfg Inc is recalling first aid kits and cabinets containing Medi-First medication components due to manufacturing practice deviations at the component supplier.

    Product
    The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW…
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Drugs)·D-0835-2022·2022-05-11

    Losartan potassium and hydrochlorothiazide tablets recalled for manufacturing quality deviations

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets due to manufacturing quality issues with chemical impurity levels above acceptable limits. Affected lots were distributed nationwide in 30-, 90-, and 1000-count bottles.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0833-2022·2022-05-11

    Losartan Potassium Tablets Recalled for Manufacturing Impurity Above Acceptable Limits

    Macleods Pharma USA is recalling Losartan Potassium 50 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Affected lots: BLI2002A, BLI2004A, and BLI2104B.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0829-2022·2022-05-11

    Norepinephrine Injection Recalled Nationwide for Manufacturing Quality Deviations

    SCA Pharmaceuticals recalled 120 bags of Norepinephrine 8mg injection nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall was initiated April 25, 2022.

    Product
    Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0799-2022·2022-05-04

    T-105 Injectable Drug Recalled for Manufacturing Practice Deviations

    Olympia Compounding Pharmacy is recalling T-105 injectables nationwide due to manufacturing process deviations. Environmental and personnel monitoring failures prior to October 2021 were not properly investigated.

    Product
    T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0794-2022·2022-05-04

    FDA Recalls Lidocaine-Prilocaine Topical Cream for Manufacturing Practice Violations

    Teva Pharmaceuticals initiated a voluntary recall of Lidocaine-Prilocaine Cream due to manufacturing practice violations. The recall affects 353,964 units distributed nationwide.

    Product
    Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0802-2022·2022-05-04

    Olympia Pharmacy Recalls AT-1 Injectable Drug Due to Manufacturing Deviations

    Olympia Compounding Pharmacy is recalling AT-1 injectable medication due to manufacturing control violations. Environmental and personnel monitoring failures may have affected product quality.

    Product
    AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0039-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0825-2022·2022-05-04

    Ultratest testosterone injection recalled for manufacturing monitoring deviations

    Olympia Compounding Pharmacy recalled 1,276 vials of Ultratest testosterone injection nationwide. Prior to October 2021, the manufacturer failed to properly investigate environmental and personnel monitoring deviations per FDA manufacturing standards.

    Product
    Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0058-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0781-2022·2022-04-27

    Sermorelin Acetate Injection Recalled Due to Sterility Assurance Issues

    Sermorelin Acetate injectable (76 vials) recalled nationwide due to manufacturing deviations that compromise sterility assurance. No illnesses reported.

    Product
    Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0784-2022·2022-04-27

    Hand Sanitizer Recalled Over Manufacturing Quality Deviations

    VIRGIN SCENT INC has recalled 46,368 bottles of artnaturals Hand Sanitizer nationwide due to manufacturing process deviations. The affected lots were produced using common ingredients from a contaminated batch.

    Product
    artnaturals Hand Sanitizer
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0783-2022·2022-04-27

    FDA Recalls artnaturals Scent-Free Hand Sanitizer for Manufacturing Deviations

    artnaturals Scent-Free Hand Sanitizer is recalled due to manufacturing process deviations. Approximately 570,268 bottles distributed nationwide are affected.

    Product
    artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0768-2022·2022-04-20

    Clobetasol Propionate Lotion Recalled Due to Manufacturing Deviations

    Preferred Pharmaceuticals is recalling Clobetasol Propionate Lotion 0.05% distributed in Illinois due to manufacturing deviations and discontinued stability study program. Consumers should contact their healthcare provider.

    Product
    Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0678-2022·2022-03-30

    Desoximetasone Ointment USP Recalled by Teligent Pharma

    Teligent Pharma is recalling Desoximetasone Ointment USP 0.25% in all sizes nationwide due to cGMP deviations related to discontinuation of the stability study program.

    Product
    Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0704-2022·2022-03-30

    Lidocaine Cream 4% Recalled Due to Manufacturing Quality Deviations

    Teligent Pharma is recalling all unexpired batches of Lidocaine Cream 4% (30-gram tubes) nationwide because the company is discontinuing its stability study program, a violation of manufacturing standards.

    Product
    Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0684-2022·2022-03-30

    Fluocinonide Gel Recalled for Manufacturing Process Deviations

    Teligent Pharma, Inc. is recalling all Fluocinonide Gel USP 0.05% nationwide within expiration date due to manufacturing deviations related to discontinued stability studies.

    Product
    Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0715-2022·2022-03-30

    Rock Town Distillery Hand Sanitizer Recall Due to Chemical Contamination

    Rock Town Distillery is recalling hand sanitizer products distributed in Arkansas due to FDA findings of acetal and acetaldehyde above specification limits resulting from manufacturing deviations.

    Product
    ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery…
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0672-2022·2022-03-30

    Clobetasol Propionate Lotion recall due to manufacturing deviations

    Teligent Pharma is recalling 35,180 bottles of Clobetasol Propionate Lotion 0.05% nationwide due to manufacturing deviations and discontinued stability testing. No illnesses reported.

    Product
    Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0685-2022·2022-03-30

    Fluocinonide Topical Solution Recalled Due to Manufacturing Deviations

    Teligent Pharma recalled Fluocinonide Topical Solution USP 0.05% nationwide because the manufacturer is discontinuing stability testing. Without ongoing verification, the company cannot ensure product safety.

    Product
    Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0654-2022·2022-03-23

    Alprazolam Tablets Recalled Due to Potential Cross-Contamination

    Golden State Medical Supply Inc. is recalling Alprazolam Tablets, USP 1mg (180-count bottles, Lot #GS027852) due to potential cross-contamination with other drug substances during manufacturing.

    Product
    Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0642-2022·2022-03-09

    Alprazolam Tablets 1mg Recalled for CGMP Deviations

    Preferred Pharmaceuticals is recalling 276 bottles of Alprazolam Tablets USP 1mg (generic Xanax) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.

    Product
    Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0599-2022·2022-03-02

    Equate Children's Pain and Fever recalled due to contaminated excipient

    Perrigo Company is recalling Equate Children's Pain and Fever (Acetaminophen) oral suspension nationwide due to manufacturing deviations involving contaminated excipient from a supplier.

    Product
    EQUATE CHILDRENS PAIN AND FEVER — EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide