FDA Recalls in 2025
2,242 recalls found
December 2025
Deep-brand Premium Select Guvar KEEP FROZEN a) Net Wt. 12 oz. (340 g); b) Net Wt. 2 LB (907 g)
Product tested positive Salmonella .
Deep-brand Indian Kitchen Quick Cubes Ready for Cooking Ginger Garlic of India Net Wt. 10 oz. (283 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand PREMIUM Select Amla Slices KEEP FROZEN Net Wt. 10 oz. (283 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Red Pearl Onions Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand PREMIUM Select Aviyal Mix KEEP FROZEN Net Wt. 14.1 oz. (400 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Diced Green Mango KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand Premium Select Methi Blocks KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand Premium Select Punjabi Tinda KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Red Guava Slices KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Dudhi (Lauki) Diced Bottle Gourd KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Sticker label (for Loose Bulk - yellow peaches): 4044
Potential contamination with Listeria monocytogenes.
Outer-packaging: gimme! brand Decaf de Agua coffee pods, Net Wt. 4.23 oz, UPC 051497457990, box of 10 pods Inner-packaging/pod packaging: gimme! coffee Deep Disco caffeinated coffee pods
Undeclared caffeine
Deep-brand Select Tindora Net Wt. 1 LB 8 oz. (24 oz.) (680 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand Select Chauri Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
3 B Cookware 4
Potential contamination due to leachable lead.
Deep-brand PREMIUM Select Amla KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Turmeric Yellow Haldi KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Sticker label (for Loose Bulk - peppermint peaches): 4401
Potential contamination with Listeria monocytogenes.
Deep-brand Premium Select Surti Papdi Whole Net Wt. 12 oz. (340g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand PREMIUM Select Green Peas KEEP FROZEN a) Net Wt. 3.85 LB. (1.75 kg); b) Net Wt. 2 LB. (907 g)
Product tested positive Salmonella .
1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 packs, or 6 packs 2. ByHeart Whole Nutrition Infant Formula Anywhere Packs Single Serve Packet 17 grams in packages containing 14 Single Serve Packets
Contaminated with Clostridium botulinum
UPC 8 10248 03186 1 Peppermint Peach PRODUCE OF U.S.A. NET WT. 2 LBS. (907G) MOONLIGHT PACKING CORPORATION REEDLEY, CA 93654
Potential contamination with Listeria monocytogenes.
Stuffed Foods brand Cacio e Pepe Arancini; KEEP FROZEN; For institutional use only; Ready-to-cook; Cook to internal temp. of 165oF; Case pack: 3/3 lbs; Net Weight: 9lbs; UPC 00819985020787
Undeclared Soy Protein Concentrate
Deep-brand Premium Select Surti Papdi Lilva Net Wt. 12 oz. (340g) KEEP FROZEN
Product tested positive Salmonella .
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
NuMED sent a "URGENT: MEDICAL DEVICE RECALL" letter dated 4/21/2025 via email on 4/21/2025 to their single customer. The customer was instructed to immediately return the affected units as soon as possible. If you have any questions or concerns, please contact Regulatory Affairs Manager at (315) 328-4491, or via email at nlaflesh@numedusa.com.
CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f.
Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
CAREstream Medical Ltd. notified its customers on or about 05/15/2015 via a Medical Device Product Correction letter. The letter informed customers to return their units, (model number: CMI-0100-PNX-xxx) for inspection and upgrade at the firms service center in Florida. So as to allow the customer's continued use of the devices safely during this process (and until all units are upgraded), CAREsteam recommends the device only be used with an oxygen monitor with alarms, attached to the device in accordance with our product manual (refer to Users Manual (revision 6) for instructions). Customers were also instructed to fax or email CAREstream Medical Ltd. to acknowledge receipt of the Medical Device Product Correction letter.
Deep-brand Premium Select Karela Ring Cut KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand Select Val Papdi Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand PREMIUM Select Jamun KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand Ponk With Tangy Sev KEEP FROZEN Net Wt. 6 oz. (170 g)
Product tested positive Salmonella .
Deep-brand Premium Select Sambhar Mix KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Oven Dried Fish (SCOMBEROMORUS CAVALLA); distributed to walk-in customers of African Food on Wheels Inc. located at 1376 Randall Avenue, Bronx, NY 10474 only; Product is packed in a corrugated brown box.
Clostridium botulinum (uneviscerated fish)
Deep-brand Premium Select Surti Undhiu Mix Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand PREMIUM Select Lotus Root (Ring Cut) Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Prairie Farms Fat Free Milk, 1 Gallon (3.78L) plastic jug, UPC 7273023117
Product may contain food-grade cleaning agents
Deep-brand PREMIUM Select Snake Gourd Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand Premium Select Chikoo Slices KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Green Channa Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.
cGMP deviations
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.
cGMP deviations
Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.
cGMP deviations
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
CGMP Deviations
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.
cGMP deviations
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
cGMP deviations
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.
cGMP deviations
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
Defective Container - A defect in the side-seal which allows leakage of product.