FDA Recall
🇺🇸 United States
TerminatedTerminated: May 2, 2025Historical recordClass II
Giant Eagle, Inc.
- Product
- Multigrain Sourdough Freshly Backed, and Half Multigrain Sou…
- Reason
- Firm is recalling product due to the potential of foreign material (glass)
- Published
- May 7, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 17, 2026Historical recordClass II
Gordon Desserts DBA Mochidoki
- Product
- Sundae Shoppe, Cookies and Cream Mochi Ice Cream, 6 count, 7…
- Reason
- Undeclared Wheat and Soy
- Published
- May 7, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 15, 2025Historical recordClass II
Upper Crust Bakery LP
- Product
- Whole Grain Multigrain , 20 oz, Paper carton (corrugated),…
- Reason
- Glass fragment found on top of bread.
- Published
- May 7, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 15, 2025Historical recordClass II
Upper Crust Bakery LP
- Product
- Multigrain Sourdough , 18 oz, Paper carton (corrugated), CP…
- Reason
- Glass fragment found on top of bread.
- Published
- May 7, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 15, 2025Historical recordClass II
Upper Crust Bakery LP
- Product
- Ancient Grains Hoagie Roll, 4 oz, Paper carton (corrugated)…
- Reason
- Glass fragment found on top of bread.
- Published
- May 7, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
TerminatedTerminated: March 6, 2026Historical recordClass III
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.
by OurPharma LLC
- Reason
- Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
by RemedyRePack Inc.
- Reason
- CGMP Deviations
- Published
- April 30, 2025
- Distribution
- PA
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FDA Recall
TerminatedTerminated: January 5, 2026Historical recordClass II
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, 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 18-month long term stability study.
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Lack of Assurance of Sterility: Leaking/damaged syringes.
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Lack of Assurance of Sterility: Leaking/damaged syringes.
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Lack of Assurance of Sterility: Leaking/damaged syringes.
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Lack of Assurance of Sterility: Leaking/damaged syringes.
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 10, 2025Historical recordClass II
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY
by Medisca Inc.
- Reason
- CGMP Deviations
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Lack of Assurance of Sterility: Leaking/damaged syringes.
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.
by Amerisource Health Services LLC
- Reason
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.
by Amerisource Health Services LLC
- Reason
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.
by Amerisource Health Services LLC
- Reason
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Published
- April 30, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 14, 2025Historical recordClass II
S Martinelli & Company
- Product
- Apple Juice; clear/translucent bulbous/round glass bottle wi…
- Reason
- Potential contamination with patulin.
- Published
- April 30, 2025
- Distribution
- Multiple states
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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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