FDA Recall
🇺🇸 United States
TerminatedTerminated: April 25, 2024Historical recordClass III
Pepsico Inc.
- Product
- 12 oz Aluminum cans of root beer packaged 12 cans per carton…
- Reason
- Product was mislabeled. Can labeled as regular Mug contains Mug Zero Sugar
- Published
- May 1, 2024
- Distribution
- Multiple states
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FDA Recall
CompletedHistorical recordClass II
S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
by Specialty Process Labs LLC
- Reason
- Failed Stability Specifications
- Published
- April 24, 2024
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01
by Eli Lilly & Company
- Reason
- CGMP Deviations
- Published
- April 24, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 16, 2024Historical recordClass III
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10
by Novitium Pharma LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- April 24, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 21, 2025Historical recordClass I
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Superpotent Drug: Due to overfilling of drug powder
- Published
- April 24, 2024
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass III
NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03
by Esperion
- Reason
- Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
- Published
- April 24, 2024
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
by Specialty Process Labs LLC
- Reason
- Failed Stability Specifications
- Published
- April 24, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 23, 2024Historical recordClass I
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
by AvKARE
- Reason
- Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
- Published
- April 24, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10
by Eugia US LLC
- Reason
- Presence of Particulate Matter
- Published
- April 17, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
by Teva Pharmaceuticals USA, Inc
- Reason
- Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
- Published
- April 17, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 6, 2026Historical recordClass II
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
by NATCO Pharma Limited
- Reason
- CGMP Deviations
- Published
- April 17, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 4, 2025Historical recordClass II
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06
by Lupin Pharmaceuticals Inc.
- Reason
- Subpotent Drug
- Published
- April 17, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 11, 2024Historical recordClass I
Backstage Center DBA CTC Seller
- Product
- Alipotec Raiz de Tejocote dietary supplements, Net. Wt. 0.35…
- Reason
- The "Alipotec King" Alipotec Raiz de Tejocote product was found to contain toxic yellow oleander instead of tejocote.
- Published
- April 17, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 30, 2025Historical recordClass III
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.
by X-Gen Pharmaceuticals Inc.
- Reason
- Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
- Published
- April 10, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 30, 2025Historical recordClass III
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
by X-Gen Pharmaceuticals Inc.
- Reason
- Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
- Published
- April 10, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
by IntegraDose Compounding Services LLC
- Reason
- Lack of Assurance of Sterility: leaking bags
- Published
- April 10, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 1, 2025Historical recordClass II
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
by B. Braun Medical Inc
- Reason
- Lack of assurance of sterility: bags have the potential to leak..
- Published
- April 10, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
- Published
- April 10, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
by Par Sterile Products LLC
- Reason
- Presence of Particulate Matter.
- Published
- April 3, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 6, 2025Historical recordClass II
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62
by Teva Pharmaceuticals USA, Inc
- Reason
- Failed Dissolution Specifications
- Published
- April 3, 2024
- 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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