FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Hi-Tech Pharmaceuticals Inc.
- Product
- HI-TECH PHARMACEUTICALS PINE BARK SUPPORTS HEART HEALTH & CI…
- Reason
- Unapproved Drug Claims and Misbranded.
- Published
- September 24, 2025
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Hi-Tech Pharmaceuticals Inc.
- Product
- HI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER HPLC V…
- Reason
- Unapproved Drug Claims.
- Published
- September 24, 2025
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Hi-Tech Pharmaceuticals Inc.
- Product
- HI-TECH PHARMACEUTICALS JOINT-RX DIETARY SUPPLEMENT 600mc He…
- Reason
- Unapproved Drug Claims.
- Published
- September 24, 2025
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Hi-Tech Pharmaceuticals Inc.
- Product
- HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/…
- Reason
- Unapproved Drug Claims.
- Published
- September 24, 2025
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Hi-Tech Pharmaceuticals Inc.
- Product
- HI-TECH PHARMACEUTICALS BETA SITOSTEROL (715MG PINE DERIVED…
- Reason
- Unapproved Drug Claims and Misbranded.
- Published
- September 24, 2025
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Hi-Tech Pharmaceuticals Inc.
- Product
- HI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID WI…
- Reason
- Unapproved Drug Claims and Misbranded.
- Published
- September 24, 2025
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Hi-Tech Pharmaceuticals Inc.
- Product
- FORMUTECH NUTRITION FLEXIBLE JOINT FORMULA WITH CISSUS QUADR…
- Reason
- Unapproved Drug Claims.
- Published
- September 24, 2025
- Distribution
- Product was shipped to the following sta…
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FDA Recall
Ongoing
Historical recordClass II
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
by AvKARE
- Reason
- Presence of a foreign substance.
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
by AvKARE
- Reason
- Presence of a foreign substance.
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808, NDC 84803-110-01 (15 mL Velvet Screen), UPC 9355909005757.
by GRACE & FIRE PTY LTD
- Reason
- Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106-02, UPC 9355909005924, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808.
by GRACE & FIRE PTY LTD
- Reason
- Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 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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