The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

376–400 of 2738

  • LowFDA (Food)·F-0474-2021·2021-05-12

    Thai Home Sweet Chili Paste Recalled for Acidified Food Rule Violations

    Jansala & Foods LLC is recalling Thai Home Sweet Chili Paste for failing to follow acidified food regulations. The product was distributed to retailers in California, Oregon, and Washington.

    Product
    Thai Home brand Sweet Chili Paste (Num Prik Pao) packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004054 Manufactured by: Jansala & Foods LLC 1813 NE 2nd Avenue Portland, OR [email protected] Distributed by: Earthly Gourmet…
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-0340-2021·2021-05-05

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity

    Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% due to failed impurity specifications. The product is distributed nationwide in 15-gram tubes.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1492-2021·2021-05-05

    Boston Scientific Recalls EXALT Controllers Due to Suboptimal Brightness Settings

    Boston Scientific is recalling three EXALT Controllers because they may have been programmed with suboptimal brightness settings, resulting in darker than desired images.

    Product
    EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1502-2021·2021-05-05

    Medela AXS Universal Aspiration Tubing Recalled for Incorrect Expiration Date

    Medela is recalling AXS Universal Aspiration Tubing because the label displays an incorrect expiration date of 2023-07-24 instead of 2021-07-24.

    Product
    Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0357-2021·2021-05-05

    Genentech Recalls Evrysdi Oral Solution Due to Defective Bottle Adapters

    Genentech is recalling 2,627 bottles of Evrysdi (risdiplam) for oral solution because some have incorrect press-in-bottle-adapters that do not fit co-packed syringes.

    Product
    Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0339-2021·2021-05-05

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity Failures

    Teligent Pharma is recalling 79,416 tubes of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) because the product failed impurity specifications.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0338-2021·2021-05-05

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity Failure

    Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% because it failed impurity specifications for a known degradation product.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0442-2021·2021-04-28

    Thai Home Yellow Curry Paste Recalled for Elevated Water Activity

    Jansala & Foods LLC is recalling 165 cases of Thai Home brand Yellow Curry Paste due to elevated water activity levels in shelf-stable products.

    Product
    Thai Home brand Yellow Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004030 Manufactured by: Jansala & Foods LLC 1620 SE 3rd Ave Portland, OR 97214 [email protected] Distributed by: Earthly Gourmet 2143 SE…
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-0331-2021·2021-04-21

    Teligent Pharma Recalls Lidocaine Ointment for Failed Stability Specifications

    Teligent Pharma is recalling Lidocaine Ointment USP, 5%, due to failed viscosity specifications. The recall covers 62,040 tubes distributed nationwide.

    Product
    Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0330-2021·2021-04-21

    Enovachem Recalls Methylprednisolone Tablets Due to Illegible Labeling

    Enovachem Pharmaceuticals is recalling Methylprednisolone Tablets due to misaligned printing on the blister card that renders dosing instructions illegible.

    Product
    Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03…
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Food)·F-0436-2021·2021-04-14

    Sea World Recalls Crimson Snapper Fillets Due to Decomposition

    Sea World, LLC is voluntarily recalling 298 cases of Crimson Snapper Fillets due to fish decomposition. The product was distributed domestically in Puerto Rico.

    Product
    Crimson Snapper Fillet, Natural Cut CO Treated, Net WT 10 LBS, Size 10/12 oz
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-0325-2021·2021-04-14

    Sun Pharmaceutical Recalls Metformin Hydrochloride Extended-Release Tablets

    Sun Pharmaceutical Industries is recalling 2,520 bottles of Metformin Hydrochloride Extended-Release Tablets due to failed moisture limits.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0321-2021·2021-04-14

    Washington Homeopathic Recalls Macula Pellets Due to Ingredient Error

    Washington Homeopathic Products, Inc. is recalling Macula Pellets Homeopathic Medicine because the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

    Product
    Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Drugs)·D-0322-2021·2021-04-14

    Washington Homeopathic Products Recalls Sp-4 Solution Due to Ingredient Error

    Washington Homeopathic Products, Inc. is recalling 114 bottles of Sp-4 solution because the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

    Product
    Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Food)·F-0384-2021·2021-04-14

    CVS Live Better Vitamin D3 Recalled for Stability Issues

    New Generation Wellness Inc. is recalling Live Better vegan vitamin D-3 tablets because stability samples showed less than 100% of the label claim.

    Product
    Live Better vegan vitamin d-3 by CVS Health, 50 mcg (2000 IU), 40 tablets in blue PET jar, Distributed by: CVS Pharmacy, Inc. one CVS Drive, Woonsocket, RI 02895, UPC 0 50428 62499 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0314-2021·2021-04-07

    Cardinal Health Recalls Tremfya Injection Due to Temperature Abuse

    Cardinal Health Inc. is voluntarily recalling 48 boxes of Tremfya (guselkumab) Injection due to temperature abuse. The affected product was distributed to Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    TREMFYA — TREMFYA (GUSELKUMAB)
    Category
    Drug
    Distribution
    4 states
  • LowFDA (Devices)·Z-1310-2021·2021-04-07

    Arthrex Recalls Cannulated Drill Bits Due to Incorrect Color Indicator

    Arthrex, Inc. is recalling 9 units of 5.0 mm cannulated drill bits because the color indicator on the shaft is the incorrect color.

    Product
    Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowNHTSA·21V237000·2021-04-05

    Mercedes-Benz Sprinter VIN Mismatch Recall

    Daimler Vans USA is recalling one 2019 Mercedes-Benz Sprinter because its VIN numbers do not match, potentially preventing owners from receiving safety recall notices.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER (VS30)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0306-2021·2021-03-24

    Edge Pharma Recalls Methacholine Challenge Test Kits Due to Storage Labeling Error

    Edge Pharma is recalling Methacholine Challenge 5-Syringe Test Kits because they were labeled with incorrect room temperature storage conditions instead of the required refrigerated conditions.

    Product
    Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0364-2021·2021-03-24

    Electrolit Fruit Punch Zero Recalled for Undeclared Red Dye

    Laboratorios Pisa Sa De Cv is recalling 571,590 bottles of Electrolit Fruit Punch Zero because the product contains undeclared FD&C Red No. 40.

    Product
    Electrolit Fruit Punch Zero, 625ML/21OZ packaged in a polypropylene bottle with volume capacity of 625mL and with a polypropylene lid and liner with a high-density polyethylene safety ring.
    Category
    Food
    Distribution
    22 states
  • LowFDA (Drugs)·D-0309-2021·2021-03-24

    Teva Recalls Romidepsin Injection Vials Due to Impurity Failures

    Teva Pharmaceuticals is recalling 1,416 vials of Romidepsin Injection because stability testing revealed out-of-specification impurities.

    Product
    Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0307-2021·2021-03-24

    Edge Pharma Recalls Epinephrine/Lidocaine Ophthalmic Solution Due to Labeling Errors

    Edge Pharma, LLC is recalling 60 syringes of Epinephrine/Lidocaine HCl sterile ophthalmic solution for injection due to incorrect or missing lot and expiration dates.

    Product
    Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
    Category
    Drug
    Distribution
    1 state
  • 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