RIJ Recalls Gericare Iron Supplement Elixir Due to Microbial Count
RIJ Pharmaceutical LLC is recalling Gericare Iron Supplement Elixir due to out-of-specification microbial counts in a water sample.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations involving microbial counts in a water sample, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported illness.
Plain-English summary
RIJ Pharmaceutical LLC is recalling Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles. The recall involves 8,124 bottles distributed nationwide in the USA. The specific lot number is 4780111 with an expiration date of 08/19.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an out-of-specification total aerobic microbial count was detected in a water sample. The FDA has classified this recall as Class II.
Consumers should check their inventory for the specific lot number and expiration date listed above. If the product matches these details, it should be returned to the point of purchase or disposed of according to local regulations.
The recalled product
- Product
- Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167
- Manufacturer
- RIJ Pharmaceutical LLC
- Category
- Drug — Supplement
- Hazard
- Affected units
- 8,124
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 4780111
- Exp. 08/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by RIJ Pharmaceutical LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · RIJ Pharmaceutical LLC
See all →- ModerateRIJ Pharmaceutical Recalls Acetaminophen Elixir Due to Microbial Count
FDA (Drugs) · 2018-06-20
- ModerateRIJ Pharmaceutical Recalls Children's Acetaminophen Elixir Due to Microbial Count
FDA (Drugs) · 2018-06-20
- ModerateRIJ Pharmaceutical Recalls Ritussin DM Due to Microbial Count Deviation
FDA (Drugs) · 2018-06-20
- ModerateRIJ Recalls Gericare Diocto Liquid Due to Microbial Count Deviation
FDA (Drugs) · 2018-06-20
- ModerateGeriCare Senna Syrup Recalled for Microbial Contamination
FDA (Drugs) · 2018-06-20
Same hazard · microbial contamination
See all →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15