FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
The Sausage Maker, Inc.
- Product
- The Sausage Maker Instacure #1
- Reason
- Contains Sodium Nitrite recalled for potential metal contamination
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Abbott Laboratories
- Product
- Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in fo…
- Reason
- Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
- Published
- November 15, 2023
- Distribution
- Alabama, Arkansas, Arizona, California,…
View recall →
FDA Recall
Terminated
Historical recordClass III
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Impurities/Degradation Specifications
- Published
- November 8, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-590-88
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- November 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- November 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15
by Safecor Health, LLC
- Reason
- CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
- Published
- November 8, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01
by Padagis US LLC
- Reason
- Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
- Published
- November 8, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01
by Edenbridge Pharmaceuticals, LLC
- Reason
- Subpotent Drug
- Published
- November 8, 2023
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8
by GlaxoSmithKline Consumer Healthcare Holdings LLC
- Reason
- Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
- Published
- November 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7
by GlaxoSmithKline Consumer Healthcare Holdings LLC
- Reason
- Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
- Published
- November 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6
by GlaxoSmithKline Consumer Healthcare Holdings LLC
- Reason
- Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
- Published
- November 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8
by GlaxoSmithKline Consumer Healthcare Holdings LLC
- Reason
- Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
- Published
- November 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2
by GlaxoSmithKline Consumer Healthcare Holdings LLC
- Reason
- Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
- Published
- November 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5
by GlaxoSmithKline Consumer Healthcare Holdings LLC
- Reason
- Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
- Published
- November 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3
by GlaxoSmithKline Consumer Healthcare Holdings LLC
- Reason
- Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
- Published
- November 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Select Custom Solutions, LLC
- Product
- JayRobb Vanilla Flavored Egg White Protein Powder. Net Weig…
- Reason
- foreign material - plastic
- Published
- November 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Braga Fresh Foods
- Product
- Wegman's Organics Sweet Kale Chopped Salad Kit, 8oz.
- Reason
- Undeclared egg
- Published
- November 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Labeling: Not Elsewhere Classified
- Published
- November 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Labeling: Not Elsewhere Classified
- Published
- November 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Labeling: Not Elsewhere Classified
- Published
- November 1, 2023
- 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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