FDA Recall
TerminatedTerminated: April 14, 2022Historical recordClass II
Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Microbial Contamination of Non-Sterile Product
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 28, 2022Historical recordClass II
Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- April 21, 2021
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 16, 2021Historical recordClass II
Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Mandideep 462 046, India.
by Lupin Pharmaceuticals Inc.
- Reason
- Superpotent Drug
- Published
- April 21, 2021
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 3, 2024Historical recordClass III
Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.
by Teligent Pharma, Inc.
- Reason
- Failed Stability Specifications: product did not meet viscosity results.
- Published
- April 21, 2021
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 13, 2022Historical recordClass III
Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10
by Macleods Pharma Usa Inc
- Reason
- Failed Impurities/Degradation Specifications
- Published
- April 21, 2021
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: August 26, 2021Historical recordClass I
Harris Teeter
- Product
- HARRIS TEETER FRESH FOODS MARKET 3 Layer COOKIES & CREME CAK…
- Reason
- The firm was notified by their contract manufacture that the product contains undeclared hazelnuts.
- Published
- April 21, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 28, 2021Historical recordClass II
Starwest Botanicals, Inc
- Product
- Starwest Botanicals Item#: 209617-34, Item# 209617-31 Woo…
- Reason
- Presence of E. coli species
- Published
- April 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 7, 2022Historical recordClass II
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
by X-Gen Pharmaceuticals Inc.
- Reason
- Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
- Published
- April 14, 2021
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 17, 2023Historical recordClass II
Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
by Cosette Pharmaceuticals, Inc.
- Reason
- CGMP Deviaitons
- Published
- April 14, 2021
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 5, 2022Historical recordClass I
Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30
by Alembic Pharmaceuticals Limited
- Reason
- Labeling: Label-mixup
- Published
- April 14, 2021
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 14, 2022Historical recordClass III
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Moisture Limits: Out of specification for water content
- Published
- April 14, 2021
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0
by Apotex Corp.
- Reason
- Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
- Published
- April 14, 2021
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 21, 2021Historical recordClass II
Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1
by Kimberly-Clark Corporation
- Reason
- Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer
- Published
- April 14, 2021
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 22, 2022Historical recordClass III
New Generation Wellness Inc.
- Product
- VEGAN VITAMIN D3, 50 mcg (2,000 IU), 60 VEGAN TABLETS in 100…
- Reason
- Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 22, 2022Historical recordClass III
New Generation Wellness Inc.
- Product
- Live Better vegan vitamin d-3 by CVS Health, 50 mcg (2000 IU…
- Reason
- Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 8, 2021Historical recordClass I
Simply Delicious Inc.
- Product
- Bobo's Maple Pecan Oat Bars, 3 oz., UPC 8 2926200021 0, Best…
- Reason
- Two consumer complaints were received for peanuts in maple pecan bars.
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4.
by Ferring Pharmaceuticals Inc
- Reason
- Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 7, 2023Historical recordClass II
ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 18031 5.
by Ferring Pharmaceuticals Inc
- Reason
- Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 23, 2022Historical recordClass I
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Crystallization: customer complaints for crystallization in finished product.
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 23, 2022Historical recordClass I
Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Crystallization: customer complaints for crystallization in finished product.
- Published
- April 7, 2021
- 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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