DrugOct 22, 2025
Atorvastatin Calcium Tablets USP, 10 mg recall — FDA D-0017-2026
Failed Dissolution Specifications
Class IIFDA: OngoingAscend Laboratories, LLC
October 2025 recalls — page 4
These records include useful source details for the selected month.
DrugOct 22, 2025
IntegraDose Compounding Services Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for recall — FDA D-0015-2026
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Class IFDA: OngoingIntegraDose Compounding Services LLC
DrugOct 22, 2025
Amerisource Health Services Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10) recall — FDA D-0027-2026
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity,…
Class IIFDA: OngoingAmerisource Health Services LLC
DrugOct 22, 2025
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle recall — FDA D-0029-2026
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength…
Class IIFDA: OngoingRising Pharma Holding, Inc.
FoodOct 15, 2025
El Rojo Wholesale Wheat Pellets recall — FDA H-0013-2026
Product is missing the ingredient list (which lead to missing wheat and Yellow No. 6), and a nutritional panel.
Class IIFDA: TerminatedEl Rojo Wholesale
FoodOct 15, 2025
Edens Elixirs Lifted Made-Lemon, Chewable tablet recall — FDA H-0129-2026
Undeclared Yellow #5
Class IIFDA: TerminatedEdens Elixirs, LLC
FoodOct 15, 2025
Toto S'Mores Ooey Gooey Cookie recall — FDA H-0071-2026
Product label contains conflicting statements about inclusion and being free of Soy ingredient.
Class IIFDA: TerminatedToto Foods, Inc.
FoodOct 15, 2025
Harris Teeter NET WT 5.0oz recall — FDA H-0030-2026
Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in…
Class IFDA: TerminatedHarris Teeter
FoodOct 15, 2025
M.O.M Enterprises, LLC Organic BABY bedtime drops recall — FDA H-0025-2026
Potential yeast contamination.
Class IIFDA: OngoingM.O.M Enterprises, LLC.
FoodOct 15, 2025
Edens Elixirs Lifted Made Mint flavored tablets 20mg 7OH/550mg Tablet recall — FDA H-0131-2026
Undeclared Yellow #5
Class IIFDA: TerminatedEdens Elixirs, LLC
FoodOct 15, 2025
Gansu Zhaofeng Agricultural Development Co G&L Food Dried Bean Curd Net WT 17.6 OZ recall — FDA H-0111-2026
Undeclared allergen (wheat).
Class IIIFDA: OngoingGansu Zhaofeng Agricultural Development Co., Ltd.
FoodOct 15, 2025
Edens Elixirs Eskay Brands Mint flavored tablets recall — FDA H-0130-2026
Undeclared Yellow #5
Class IIFDA: TerminatedEdens Elixirs, LLC
FoodOct 15, 2025
Organicare Nature's Science FemiClear Daily Bladder Strength Dietary Supplement, 28 Count recall — FDA H-0031-2026
Microbial contamination with Escherichia coli O7:K1 and E. Coli 1303.
Class IIFDA: TerminatedOrganicare Nature's Science, LLC
FoodOct 15, 2025
Western United Fish Company Kirkland Signature brand Ahi Tuna Wasabi Poke, Costco #17193 recall — FDA H-0023-2026
Listeria monocytogenes. Recall was initiated after being notified by green onion supplier of a Listeria monocytogenes positive test result in the green onions which were used only in Ahi…
Class IFDA: TerminatedWestern United Fish Company Inc
FoodOct 15, 2025
Harris Teeter NET WT 5.0OZ recall — FDA H-0029-2026
Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in…
Class IFDA: TerminatedHarris Teeter
FoodOct 15, 2025
Country Eggs o Nagatoshi Large AA Brown Omega-3 1 dozen cartons o Nijiya recall — FDA H-0011-2026
Shell egg product potentially contaminated with salmonella.
Class IFDA: TerminatedCountry Eggs, LLC
DrugOct 15, 2025
GenoGenix BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all recall — FDA D-0086-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingGenoGenix LLC
DrugOct 15, 2025
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose recall — FDA D-0008-2026
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class IIFDA: OngoingDr. Reddy's Laboratories, Inc.
DrugOct 15, 2025
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle recall — FDA D-0006-2026
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Class IIFDA: OngoingACCORD HEALTHCARE, INC.
DrugOct 15, 2025
Acuity Specialty Products Wyandotte, Sanifect E3, Hand Sanitizer recall — FDA D-0004-2026
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk…
Class IIFDA: OngoingAcuity Specialty Products, Inc.
DrugOct 15, 2025
GenoGenix Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and recall — FDA D-0074-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingGenoGenix LLC
DrugOct 15, 2025
Acuity Specialty Products AFCO, Hand Sanitizer recall — FDA D-0005-2026
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk…
Class IIFDA: OngoingAcuity Specialty Products, Inc.
DrugOct 15, 2025
The Harvard Drug Group LLC dba Major Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 recall — FDA D-0013-2026
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class IIFDA: OngoingThe Harvard Drug Group LLC dba Major Pharmaceuticals…
DrugOct 15, 2025
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and recall — FDA D-0007-2026
Failed Content Uniformity Specifications
Class IIFDA: OngoingAvKARE
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.