FDA Recall
Ongoing
Historical recordClass II
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
by Nostrum Laboratories, Inc.
- Reason
- CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
by Strides Pharma, Inc.
- Reason
- Failed Dissolution Specifications.
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04
by Pfizer Inc.
- Reason
- CGMP Deviations; particulates identified during visual inspection
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02
by Pfizer Inc.
- Reason
- CGMP Deviations; particulates identified during visual inspection
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
by FDC Limited
- Reason
- Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
by Lupin Pharmaceuticals Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
NuNaturals Inc
- Product
- Pure Monk Fruit Sweetener, net wt. 0.71oz. UPC 7 39223 00187…
- Reason
- Product is Stevia powder but bottle was mis-labeled as Pure Monk Fruit Sweetener.
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
NuNaturals Inc
- Product
- Organic Pure Stevia, net wt. 1oz. UPC 7 39223 00204 0. Produ…
- Reason
- Product is Monk Fruit powder but bottle was mis-labeled as Organic Pure Stevia.
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)
by Cipla USA, Inc.
- Reason
- Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
- Published
- July 30, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
- Published
- July 30, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
by Imprimis NJOF, LLC
- Reason
- Sub-Potent Drug: Subpotent assay results during stability testing.
- Published
- July 30, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
by Imprimis NJOF, LLC
- Reason
- Sub-Potent Drug: Subpotent assay results during stability testing.
- Published
- July 30, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Mondelez Global Llc
- Product
- Ritz Peanut Butter Cracker Sandwiches, Net Wt. 11.4 oz, 8 co…
- Reason
- Undeclared allergens (Peanut) due to mispackaging
- Published
- July 30, 2025
- Distribution
- The recalled product was distributed to…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Mondelez Global Llc
- Product
- Ritz Cracker Sandwiches, Variety 20 count variety Pack, (20-…
- Reason
- Undeclared allergens (Peanut) due to mispackaging
- Published
- July 30, 2025
- Distribution
- The recalled product was distributed to…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Mondelez Global Llc
- Product
- Ritz Peanut Butter Cracker Sandwiches, Net Wt. 55.2 oz, 40 c…
- Reason
- Undeclared allergens (Peanut) due to mispackaging
- Published
- July 30, 2025
- Distribution
- The recalled product was distributed to…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Mondelez Global Llc
- Product
- Ritz Peanut Butter Cracker Sandwiches, Net Wt.27.6 oz, 20 co…
- Reason
- Undeclared allergens (Peanut) due to mispackaging
- Published
- July 30, 2025
- Distribution
- The recalled product was distributed to…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224
by A.P. Deauville, LLC
- Reason
- CGMP Deviations
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194
by A.P. Deauville, LLC
- Reason
- CGMP Deviations
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313
by A.P. Deauville, LLC
- Reason
- CGMP Deviations
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18
by Ascend Laboratories, LLC
- Reason
- CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
- Published
- July 23, 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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