FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Professional Botanicals, Inc.
- Product
- Product Name: Tense-X. Package: 175cc HDPE Bottle. Type: Veg…
- Reason
- Products contains Magnesium Salicylate.
- Published
- November 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Professional Botanicals, Inc.
- Product
- Product Name: Total Comfort. Package: 175cc HDPE Bottle. Typ…
- Reason
- Products contains Magnesium Salicylate.
- Published
- November 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Professional Botanicals, Inc.
- Product
- Product Name: Nutra Calm Package: 175cc HDPE Bottle. Type: V…
- Reason
- Products contains Magnesium Salicylate.
- Published
- November 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01
by Aero Healthcare
- Reason
- Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
by Zydus Pharmaceuticals (USA) Inc
- Reason
- cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
by Zydus Pharmaceuticals (USA) Inc
- Reason
- cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
- Product
- Publix Large Shrimp Peeled & Deveined Tail On 31/40, net wt.…
- Reason
- Shrimp may be contaminated with Cesium-137 (Cs-137).
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
- Product
- Publix Extra Large Shrimp Easy to Peel Deveined 21/25, net w…
- Reason
- Shrimp may be contaminated with Cesium-137 (Cs-137).
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
- Product
- AquaStar 13/15 Raw Shrimp Easy Peel Deveined, net wt. 2 lbs.…
- Reason
- Shrimp may be contaminated with Cesium-137 (Cs-137).
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
- Product
- AquaStar 16/20 Frozen Raw EZ-Peel White Shrimp, net wt. 5 lb…
- Reason
- Shrimp may be contaminated with Cesium-137 (Cs-137).
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
- Product
- Waterfront Bistro Frozen Raw EZ-Peel White Shrimp 21/25, net…
- Reason
- Shrimp may be contaminated with Cesium-137 (Cs-137).
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
- Product
- Best Yet Frozen Raw EZ-Peel White Shrimp 16/20 (net wt. 1 l…
- Reason
- Shrimp may be contaminated with Cesium-137 (Cs-137).
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
- Product
- AquaStar Raw Peeled Tail-on Shrimp Skewers, net wt. 1.25lbs.…
- Reason
- Shrimp may be contaminated with Cesium-137 (Cs-137).
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
- Product
- Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp, net wt.…
- Reason
- Shrimp may be contaminated with Cesium-137 (Cs-137).
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
- Product
- Kroger Raw Colossal EZ Peel Shrimp, net wt. 2lbs., UPC 20011…
- Reason
- Shrimp may be contaminated with Cesium-137 (Cs-137).
- Published
- November 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- Published
- November 5, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
by Heritage Pharmaceuticals Inc
- Reason
- CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
- Published
- November 5, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-052-88.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- Published
- November 5, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-051-88.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- Published
- November 5, 2025
- 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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