The Recall Desk

Hazard

Out Of Specification recalls

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

What the numbers show

Total
261
Critical
2
Severe
6
Most recent
2026-07-29

Of the 261 out of specification recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (2%) 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 out of specification 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.

226–250 of 261

  • ModerateFDA (Drugs)·D-0889-2021·2021-10-06

    Strophanthus Hisp 30X Homeopathic Medicine Fails Identification Test

    Washington Homeopathic Products is recalling 91 bottles of Strophanthus hisp 30X for Hives due to failed identification testing. The product did not meet specifications in HPTLC analysis and was distributed nationwide.

    Product
    Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 40640 47553 9; (b) 30mL UPC 7 40640 47557 7; (c) 100mL, UPC 7 40640 47565 2; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0879-2021·2021-10-06

    Z-103 GU DETOXING Homeopathic Medicine Recall for Failed Identification Testing

    Washington Homeopathic Products is recalling Z-103 GU DETOXING, a 1000ml homeopathic medicine containing 20% alcohol, due to out-of-specification test results on identification testing using HPTLC analysis.

    Product
    Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For Manufacturing Use Only, REMEDY: Agrimonia Eupatoria 24X, Alfalfa 24X, Althaea Officinalis 24X, Avena Sativa 24X, Boldo 24X, Carduus Marianus 24X, Chioanathus Virginica 24X, Cynara Scolymus 24X, Iria Ver
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0864-2021·2021-10-06

    Washington Homeopathic Cinnamomum Pills Recalled for Failed Identity Testing

    Washington Homeopathic Products is recalling Cinnamomum 6X and 30X homeopathic pills due to failed identification testing results. The products did not meet specifications in HPTLC analysis.

    Product
    Cinnamomum 6X, Flatulence* Sucrose/Lactose Pills, Packaged as a) 4 Dram, b) 1 oz, and Cinnamomum 30X, Flatulence* Sucrose/Lactose Pills, Packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0894-2021·2021-10-06

    Aconitum nap Fear Homeopathic Medicine Recalled for Failed Product Identification Testing

    Washington Homeopathic Products is recalling Aconitum nap Fear 20% Alcohol homeopathic medicine (Lot #26198) distributed nationwide due to out-of-specification test results from HPTLC identification analysis.

    Product
    Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers Aconitum nap Fear* 20% Alcohol HPUS: 7X, 12X, packaged in 15mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0884-2021·2021-10-06

    Z-1070 Formula Anxioheal Homeopathic Medicine Recall for Testing

    Washington Homeopathic Products, Inc. is recalling Z-1070 Formula Anxioheal, a 1000ml homeopathic remedy containing 20% alcohol, due to out-of-specification test results from HPTLC identification testing. The product was distributed nationwide.

    Product
    Z-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY:Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricu
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0876-2021·2021-10-06

    Washington Homeopathic Products Cistus Canadensis Drops Recall

    Washington Homeopathic Products is recalling Cistus Canadensis 5X Coldness 20% Alcohol drops (15ml and 50ml bottles) distributed nationwide due to out-of-specification identification test results.

    Product
    Cistus Canadensis 5X Coldness* 20% Alcohol drops, Packaged in a) 15ml; b) 50 ml; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0802-2021·2021-09-22

    Betamethasone Dipropionate Lotion recalled for unknown impurity

    Akorn, Inc. is recalling Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, due to an unknown impurity found in the product that exceeds specification limits. The affected lots were distributed nationwide.

    Product
    Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0761-2021·2021-09-01

    PDI Povidone-Iodine Swabstick Prep Pads Recalled for Subpotency

    Professional Disposables International is recalling PDI Povidone-Iodine Swabsticks nationwide because the product is subpotent—meaning the active ingredient is below the required specification.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0760-2021·2021-09-01

    PVP Iodine Prep Pads Recalled for Potency Below Specification

    Professional Disposables International is recalling PVP Iodine Prep Pads distributed nationwide because the product is subpotent—meaning the active ingredient strength falls below FDA specifications. Affected lots were distributed across the United States.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0762-2021·2021-09-01

    PDI Povidone-Iodine Cleansing Scrub Swabstick Recalled for Subpotency

    Professional Disposables International is recalling PDI Povidone-Iodine Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning it contains less active ingredient than specified.

    Product
    PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • LowFDA (Drugs)·D-0655-2021·2021-07-21

    LEUKINE (Sargramostim) Injection Recalled for Failed Stability Specification

    Partner Therapeutics Inc is recalling LEUKINE (sargramostim) for injection due to an out-of-specification result observed at the 27-month stability timepoint. The recall affects 32,260 vials distributed to one government account.

    Product
    LEUKINE — LEUKINE (SARGRAMOSTIM)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0299-2021·2021-03-17

    Ferring Recalls Menopur Due to Out-of-Specification pH in Diluent

    Ferring Pharmaceuticals is recalling Menopur (menotropins) and its 0.9% Sodium Chloride diluent because the diluent failed pH specifications. The recall covers products distributed nationwide in the USA.

    Product
    MENOPUR — MENOPUR (MENOTROPINS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1513-2020·2020-08-26

    Ultra Seal Recalls Extra Strength Headache Relief Tablets for Stability Failures

    Ultra Seal Corporation is recalling 701,735 packets of Extra Strength Headache Relief tablets due to out-of-specification results for salicylic acid.

    Product
    Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2332-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 1,450 R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 7133
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2331-2020·2020-06-17

    Smith & Nephew R3 Acetabular Shells Recalled for Manufacturing Error

    Smith & Nephew is recalling R3 No Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2334-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 4,172 R3 Acetabular Shells distributed worldwide because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 713
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0659-2020·2020-01-22

    Sun Pharmaceutical Recalls Sumatriptan Succinate Tablets Due to Impurities

    Sun Pharmaceutical Industries is recalling specific lots of Sumatriptan Succinate 50 mg tablets because they failed impurity specifications.

    Product
    SUMATRIPTAN SUCCINATE — SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0621-2020·2019-12-11

    Pacira Recalls Sub-Potent Exparel Bupivacaine Injectable Vials

    Pacira Pharmaceuticals is recalling 910 vials of Exparel (Bupivacaine) because the drug was found to be sub-potent and out of specification.

    Product
    EXPAREL — EXPAREL (BUPIVACAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0143-2020·2019-10-23

    Aurobindo Recalls Amphetamine Mixed Salts Tablets for Out-of-Specification Weight

    Aurobindo Pharma USA Inc. is recalling 11,129 bottles of 20mg Amphetamine Mixed Salts tablets because they failed weight and thickness specifications.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1033-2018·2018-08-08

    Renaissance Lakewood Recalls Fluconazole Injection Bags for Out-of-Specification Levels

    Renaissance Lakewood, LLC is recalling 12,088 bags of Fluconazole Injection because the lots are out of specification for elevated sodium chloride and fluconazole assay levels.

    Product
    Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0605-2018·2018-04-04

    Renaissance Lakewood Recalls Flucanazole Injection Due to Stability Failures

    Renaissance Lakewood, LLC is recalling 1,277 bags of Flucanazole Injection due to superpotent and failed stability specifications.

    Product
    Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0680-2017·2017-05-03

    McKesson Recalls Donepezil HCl Tablets Due to Out-of-Specification Assay

    McKesson Packaging Services is recalling 476 cartons of Donepezil HCl 10mg tablets because routine stability testing revealed an out-of-specification assay result.

    Product
    Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC
    Category
    Drug
    Distribution
    3 states