FDA Recalls in 2025
2,242 recalls found
December 2025
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Sticker label (for Loose Bulk - yellow peaches): 4044
Potential contamination with Listeria monocytogenes.
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Defective container - seal not adhering to bottles
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
Failed stability specifications: Out of specification for hardness test
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
Cross Contamination with Other Products
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
Incorrect Product Formulation
Deep-brand Indian Kitchen Quick Cubes Ready For Cooking Green Chili of India Net Wt. 10 oz. (283 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand Select Bhindi Cut Okra KEEP FROZEN a) Net Wt. 12 oz (340 g); b) Net Wt. 1 LB 8 oz. (24 oz.) (680 g); c) Net Wt. 2 LB (907 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Peas and Carrots KEEP FROZEN Net Wt. 2 LB (907 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Mixed Vegetables 4 way KEEP FROZEN a) Net Wt. 3.85 LB. (1.75 kg); b) Net Wt. 2 LB (907 g)
Product tested positive Salmonella .
Deep-brand Premium Select Baby Bhindi KEEP FROZEN Net Wt. 12 oz (340 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Tapioca (Cassava) Diced KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Sweet Corn KEEP FROZEN Net Wt. 2 LB (907 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Garlic Cloves Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Shloimy's Heimishe Matjes Herring packaged in 7oz plastic container
Undeclared FD&C Red #40
Simplot¿ Traditional Reduced Sodium Tater Gems¿ , formed frozen potatoes, 6/5lb bags per case, foodservice item, master case UPC 100 71179 00418 9. Distributed by Simplot Global Food, LLC, P.O. Box 9386, Boise, ID 83707
Plastic fragments. Pieces of semi-rigid plastic embedded in the recalled Tater Gems product.
Sticker label (for Loose Bulk - peppermint peaches): 4401
Potential contamination with Listeria monocytogenes.
UPC 8 98429 00266 4 Peppermint Peach PROUCE OF U.S.A. 4 COUNT MIN. WT. 2.25 LBS MOONLIGHT PACKING CORPORATION REEDLEY, CA 93654
Potential contamination with Listeria monocytogenes.
Deep-brand Indian Kitchen Quick Cubes READY FOR COOKING Garlic of India KEEP FROZEN Net Wt. 10 oz. (283 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Falsa KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand Select Tindora Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand Premium Select Tuvar Lilva Net Wt. 1 LB 8 oz. (24 oz.) (680 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand PREMIUM Select Hot Green Chillies Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
UPC 8 10248 03087 1 Peppermint Peach WHITE PEACHES READY TO EAT FROM CALIFORNIA PRODUCE OF U.S.A. NET WT. 4 LBS. MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654 UPC 8 10248 03163 2 Peppermint Peaches WHITE PEACHES READY TO EAT FROM CALIFORNIA PRODUCE OF U.S.A. NET WT. 4 LBS. MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654
Potential contamination with Listeria monocytogenes.
Deep-brand PREMIUM Select Fansi Cut French Beans Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Doughy brand Chocolate Chip Cookie Dough; 12 oz
Product may be contaminated with Salmonella
UPC 8 98429 00209 1 PEACHES PRODUCE OF U.S.A. NET WT 2 LB (32 OZ) 907 g DISTRIBUTED BY MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654 UPC 0 11110 18174 9 PEACHES PRODUCE OF USA NET WT 32 OZ (2 LB) 907g DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202
Potential contamination with Listeria monocytogenes.
Deep-brand PREMIUM Select Green Garlic KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Dum Aloo (Cooked) Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
3 B Cookware 6
Potential contamination due to leachable lead.
Deep-brand Premium Select Suran Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
UPC 8 10248 03186 1 WHITE PEACHES CALIFORNIA FRUIT PRODUCE OF U.S.A. NET WT. 2 LBS. (907G) MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654
Potential contamination with Listeria monocytogenes.
Charlevoix Cheese Company Mild Cheddar Cheese, Net Wt. 8 oz (227g). UPC 8 50056-64205 7. 12 retail units per wholesale case.
Possible Listeria monocytogenes contamination.
Sticker label (for Loose Bulk - white peaches): 4401
Potential contamination with Listeria monocytogenes.
Deep-brand Select Arvi Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand Premium Select Ratalu Sliced Violet Indian Yams KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
3 B Cookware 5
Potential contamination due to leachable lead.
Deep-brand Premium Select Kantola KEEP FROZEN Net Wt. 12 oz. (340 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Tuvar Lilva Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand Instant Stuffing For Pani Puri KEEP FROZEN Net Wt. 1 LB. (454 g)
Product tested positive Salmonella .
Deep-brand PREMIUM Select Singoda (Cooked) Water Chestnuts Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Deep-brand PREMIUM Select Methi Chopped KEEP FROZEN Net Wt. 10 oz. (283 g)
Product tested positive Salmonella .
UPC 8 10248 03165 6 YELLOW Peaches PRODUCE OF U.S.A. NET WT. 4 LBS. MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654 UPC 8 98429 00220 6 YELLOW Peaches from California PRODUCE OF U.S.A. NET WT. 4 LBS. MOONLIGHT PACKING CORP. REEDLEY, CALIFORNIA 93654
Potential contamination with Listeria monocytogenes.
Deep-brand Select Carrots Sliced Net Wt. 12 oz. (340 g) KEEP FROZEN
Product tested positive Salmonella .
Brass Langri Cookware Sticker label: 14
Potential contamination due to leachable lead.