FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
American Blue Ribbon Holdings LLC
- Product
- 9" French Silk Base, Item 7545, Count per case 6 Ea., Case W…
- Reason
- Undeclared Pecan
- Published
- January 13, 2021
- Distribution
- Pies shipped to two distributors who shi…
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FDA Recall
Terminated
Historical recordClass I
Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9
by Wishgarden Herbs, Incorporated
- Reason
- Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
- Published
- January 6, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4
by Wishgarden Herbs, Incorporated
- Reason
- Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
- Published
- January 6, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5
by Wishgarden Herbs, Incorporated
- Reason
- Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
- Published
- January 6, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02
by Fresenius Kabi USA, LLC
- Reason
- Presence of Particulate Matter - found in reserve sample vials at the firm.
- Published
- January 6, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34
by CIPLA
- Reason
- Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- Published
- January 6, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-528-34
by CIPLA
- Reason
- Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- Published
- January 6, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34
by CIPLA
- Reason
- Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- Published
- January 6, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
by Ascend Laboratories LLC
- Reason
- Failed Impurity/Degradation Specifications
- Published
- January 6, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
by Ascend Laboratories LLC
- Reason
- Failed Impurity/Degradation Specifications
- Published
- January 6, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979
by Imprimis NJOF, LLC
- Reason
- Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
- Published
- January 6, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05
by US Compounding Inc
- Reason
- Labelling: Missing label.
- Published
- January 6, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
by Morton Grove Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
- Published
- December 30, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
by Fresenius Kabi USA, LLC
- Reason
- Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
- Published
- December 30, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232
by SCA Pharmaceuticals, Inc.
- Reason
- Subpotent drug.
- Published
- December 30, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01
by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
- Reason
- CGMP Deviations
- Published
- December 30, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Flowers Foods (Corporate Offices)
- Product
- CANYON BAKEHOUSE GLUTEN MOUNTAIN WHITE BREAD NET WT. 18oz (1…
- Reason
- The firm discovered that some of their products showed higher than acceptable levels of gluten. They placed the product on hold for destruction however, one shipper sent products into commerce for distribution.
- Published
- December 30, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Flowers Foods (Corporate Offices)
- Product
- CANYON BAKEHOUSE GLUTEN FREE BAGELS EVERYTHING NET WT. 14 OZ…
- Reason
- The firm discovered that some of their products showed higher than acceptable levels of gluten. They placed the product on hold for destruction however, one shipper sent products into commerce for distribution.
- Published
- December 30, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
Terminated
Historical recordClass II
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17
by Hikma Pharmaceuticals USA Inc.
- Reason
- Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
- Published
- December 23, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
by AVKARE Inc.
- Reason
- Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
- Published
- December 23, 2020
- 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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