FDA Recall
Ongoing
Historical recordClass II
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
by Fagron Compounding Services
- Reason
- Incorrect Product Formulation
- Published
- December 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
by Dr. Reddy's Laboratories, Inc.
- Reason
- Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- Published
- December 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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.
by Cipla USA, Inc.
- Reason
- Failed stability specifications: Out of specification for hardness test
- Published
- December 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.
by Cipla USA, Inc.
- Reason
- Failed stability specifications: Out of specification for hardness test
- Published
- December 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Moonlight Packing Corporation
- Product
- Sticker label (for Loose Bulk - peppermint peaches): 4401
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- December 17, 2025
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Moonlight Packing Corporation
- Product
- Sticker label (for Loose Bulk - peppermint peaches): 4401
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- December 17, 2025
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Moonlight Packing Corporation
- Product
- Sticker label (for Loose Bulk - white peaches): 4401
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- December 17, 2025
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Moonlight Packing Corporation
- Product
- Sticker label (for Loose Bulk - yellow peaches): 4044
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- December 17, 2025
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Moonlight Packing Corporation
- Product
- Sticker label (for Loose Bulk - yellow peaches): 4044
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- December 17, 2025
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Moonlight Packing Corporation
- Product
- UPC 8 98429 00266 4 Peppermint Peach PROUCE OF U.S.A. 4 COUN…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- December 17, 2025
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Moonlight Packing Corporation
- Product
- UPC 8 10248 03186 1 Peppermint Peach PRODUCE OF U.S.A. NET W…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- December 17, 2025
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Moonlight Packing Corporation
- Product
- UPC 8 10248 03186 1 WHITE PEACHES CALIFORNIA FRUIT PRODUCE O…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- December 17, 2025
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Moonlight Packing Corporation
- Product
- UPC 8 98429 00209 1 PEACHES PRODUCE OF U.S.A. NET WT 2 LB (3…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- December 17, 2025
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Moonlight Packing Corporation
- Product
- UPC 8 10248 03087 1 Peppermint Peach WHITE PEACHES READY TO…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- December 17, 2025
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Moonlight Packing Corporation
- Product
- UPC 8 10248 03165 6 YELLOW Peaches PRODUCE OF U.S.A. NET WT.…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- December 17, 2025
- Distribution
- Domestic: AL, AR, AZ, CA, CO, CT, FL, GA…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
ByHeart, INC.
- Product
- 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 gra…
- Reason
- Contaminated with Clostridium botulinum
- Published
- December 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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.
by Breckenridge Pharmaceutical, Inc.
- Reason
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Published
- December 10, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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.
by Breckenridge Pharmaceutical, Inc.
- Reason
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Published
- December 10, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
by Blossom Pharmaceuticals
- Reason
- cGMP deviations
- Published
- December 10, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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.
by Blossom Pharmaceuticals
- Reason
- cGMP deviations
- Published
- December 10, 2025
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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