Class II · Moderate risk
TPN bag (patient specific)
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Rheumacare capsules
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
CGMP Deviations: product found to contain lead.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
- Recalling firm
- Handelnine Global LLC
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Dec 22, 2025 · FDA notice with lot numbers
- FDA recall number
- D-0332-2026 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other cgmp deviation recalls from 2025
All cgmp deviation recalls
Class II · Moderate risk
Toothpaste: a) COLGATE
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Deodorant: a) Axe
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Petroleum jelly: a) Vaseline Petroleum Jelly
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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