Hi-Tech Pharmacal

Ferrous Sulfate Elixir

Serving

5 mL

Form

liquid

DSLD

Formula hash

170721ebd6bb

Brand context

Catalog

products

With avoid flag

products

FDA recalls

history

CAERS

reports

Recall historyObjective label signals

Flagged excipients

0 avoid · 2 caution

FDA recalls

2 Class I / II

CAERS reports

FDA consumer events

Certifications

none recorded

2 FDA recalls on file. · Every flag below links to the authority's published citation.

Supplement Facts

1 active ingredients

Ingredient	Amount	% DV
Ferrous Sulfate IronmineralUNII · 39R4TAN1VT 5 effects 4.9× ULexceeds NIH ODS adult upper limitsource →	220 mg	—

What this product supports · authorized claims

Rolled up from EFSA / FDA / NIH ODS authorized function claims on this product's active ingredients. Each row shows which ingredients contribute.

Flagged excipients

◐ CAUTIONSodium Saccharin
sweetener
Delisted from NTP Report on Carcinogens in 2000 after human-relevance re-evaluation, but California Prop 65 still lists as carcinogen (1987) for high-dose rat bladder tumors. FDA warning-label requirement was repealed 2001.
oehha.ca.gov →
◐ CAUTIONFD&C Yellow # 6
color
EU requires 'attention in children' warning per Reg 1333/2008 Annex III (Southampton study 2007). Banned in Norway + Finland; allowed in US under 21 CFR 74.706 with declaration.
eur-lex.europa.eu →

Recall history

Class III2014-08-25brand-level
Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
Reason: The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.
FDA record →
Class III2014-07-28brand-level
Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
Reason: Out-of-specification results for pH.
FDA record →

Other ingredients

purified Water · Sucrose · Corn Syrup · alcohol 5% · Sodium Benzoate · artificial cherry flavor

Chemically equivalent

Products with identical sorted (ingredient, amount) tuples.