Report cards › Food › Abbott Laboratories Inc
PEDIALYTE
CSWH grade C (69)
Method v1.0 (how we grade), based on the records below; exact score 69.
| Indicator | Grade | What we found |
|---|---|---|
| Recalls (40%) | C (60) | 2 Class II, 1 Class III (9 points) · 3 events For current recalls see FDA and USDA. |
| Ingredients (40%) | C (63) | Tier A: 0 of 41 products · A (100) (25%) Tier B: 34 of 41 products (FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, FD&C Yellow No. 5) · F (0) (15%) · products |
| FDA warning letters (20%) | A (100) | None found to the owner Oct 30, 2021 to Oct 30, 2026. |
Shown, not graded: recall reasons (2 other reasons, 1 undeclared allergen) · IARC notes (0 products) · FDA dye pledge: none on FDA's tracker.
Recalls, Oct 30, 2021 to Oct 30, 2026
Class II, Oct 13, 2022 · Other reasons · FDA event 91003, 2 products (counted once)
Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
- Reason (FDA's words)
- Compromised seal integrity which could lead to spoilage
- Code information
- Batch No. 34589N201 Case No. 34589N201 Product No. 59892 Best By 05/01/23
- Recalling firm
- Abbott Laboratories
- Dates
- Recall started Oct 13, 2022; classified Nov 16, 2022
- Status
- Terminated (status reported by FDA at classification)
- How we matched it
- matched by recalling firm (name) and brand name
FDA record F-0154-2023: openFDA · Report an error
Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case
- Reason (FDA's words)
- Compromised seal integrity which could lead to spoilage
- Code information
- Batch No. 34589N200 Case No. 34589N200 Product No. 5989213 Best By 04/01/23
- Recalling firm
- Abbott Laboratories
- Dates
- Recall started Oct 13, 2022; classified Nov 16, 2022
- Status
- Terminated (status reported by FDA at classification)
- How we matched it
- matched by recalling firm (name) and brand name
FDA record F-0155-2023: openFDA · Report an error
Class III, Jun 3, 2022 · Undeclared allergen · FDA event 90385
Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Flavor*** 6 0.6 OZ (17g) PACKETS/NET WT. 3.6 OZ (102g)***INGREDIENTS: ANHYDROUSE DEXTROSE, CITRIC ACID, POTASSIUM CITRATE***Manufactured for: Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219
- Reason (FDA's words)
- The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declared on the label.
- Code information
- 287112S00
- Recalling firm
- Abbott Laboratories
- Dates
- Recall started Jun 3, 2022; classified Jun 15, 2022
- Status
- Terminated (status reported by FDA at classification)
- How we matched it
- matched by recalling firm (name) and brand name
FDA record F-1312-2022: openFDA · Report an error
Class II, Jun 3, 2022 · Other reasons · FDA event 90379, 2 products (counted once)
Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L***INGREDIENTS: WATER, DEXTROSE*** Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA
- Reason (FDA's words)
- These products are being recalled due to the potential of leakage from the 1L container.
- Code information
- 30295SG00, 30296SG00, 30297SG00, 30298SG00, 30299SG00, 35415SG00, 35416SG00, 35417SG00, 35418SG00, 38452SG00, 38453SG00 and 38454SG00.
- Recalling firm
- Abbott Laboratories
- Dates
- Recall started Jun 3, 2022; classified Jun 22, 2022
- Status
- Terminated (status reported by FDA at classification)
- How we matched it
- matched by recalling firm (name) and brand name
FDA record F-1343-2022: openFDA · Report an error
Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemonade Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L*** INGREDIENTS: WATER, DEXTROSE***Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA
- Reason (FDA's words)
- These products are being recalled due to the potential of leakage from the 1L container.
- Code information
- 30289SG00, 30290SG00, 30291SG00, 30292SG00, 30293SG00, 30294SG00, 35409SG00, 35410SG00, 35411SG00, 35412SG00, 36435SG00, 36434SG00, 36433SG00, 36432SG00, 37444SG00, 37443SG00, 37442SG00, 37441SG00, 37440SG00, and 41129D500.
- Recalling firm
- Abbott Laboratories
- Dates
- Recall started Jun 3, 2022; classified Jun 22, 2022
- Status
- Terminated (status reported by FDA at classification)
- How we matched it
- matched by recalling firm (name) and brand name
FDA record F-1344-2022: openFDA · Report an error
2 recall events by Abbott Laboratories Inc name no brand, so they are on the owner's page, not counted here.
Store-brand and co-packer recalls count on a brand only when a UPC in the recall matches one of its products.
Ingredients on our watch list
FD&C Blue No. 1 Tier B in 21 of 41 products
- HHS/FDA phase-out of petroleum-based food dyes (announced 2025-04-22; voluntary industry pledges, no rule): FDA phase-out target, effective Dec 31, 2027.
- Texas SB 25, 89th Legislature (2025), Health and Safety Code § 431.0815 (warning label), § 431.0815(a)(7): warning label required by state law (TX), effective Jan 1, 2027. Under court challenge: American Beverage Association v. Paxton.
- West Virginia HB 2354 (2025), W. Va. Code § 16-7-2(b)(7): banned in food by state law (WV), effective Jan 1, 2028. Under court challenge (enforcement blocked for now): International Association of Color Manufacturers v. Singh.
FD&C Red No. 40 Tier B in 19 of 41 products
- HHS/FDA phase-out of petroleum-based food dyes (announced 2025-04-22; voluntary industry pledges, no rule): FDA phase-out target, effective Dec 31, 2027.
- Texas SB 25, 89th Legislature (2025), Health and Safety Code § 431.0815 (warning label), § 431.0815(a)(34): warning label required by state law (TX), effective Jan 1, 2027. Under court challenge: American Beverage Association v. Paxton.
- West Virginia HB 2354 (2025), W. Va. Code § 16-7-2(b)(7): banned in food by state law (WV), effective Jan 1, 2028. Under court challenge (enforcement blocked for now): International Association of Color Manufacturers v. Singh.
FD&C Yellow No. 6 Tier B in 6 of 41 products
- HHS/FDA phase-out of petroleum-based food dyes (announced 2025-04-22; voluntary industry pledges, no rule): FDA phase-out target, effective Dec 31, 2027.
- Texas SB 25, 89th Legislature (2025), Health and Safety Code § 431.0815 (warning label), § 431.0815(a)(44): warning label required by state law (TX), effective Jan 1, 2027. Under court challenge: American Beverage Association v. Paxton.
- West Virginia HB 2354 (2025), W. Va. Code § 16-7-2(b)(7): banned in food by state law (WV), effective Jan 1, 2028. Under court challenge (enforcement blocked for now): International Association of Color Manufacturers v. Singh.
FD&C Yellow No. 5 Tier B in 2 of 41 products
- HHS/FDA phase-out of petroleum-based food dyes (announced 2025-04-22; voluntary industry pledges, no rule): FDA phase-out target, effective Dec 31, 2027.
- Texas SB 25, 89th Legislature (2025), Health and Safety Code § 431.0815 (warning label), § 431.0815(a)(43): warning label required by state law (TX), effective Jan 1, 2027. Under court challenge: American Beverage Association v. Paxton.
- West Virginia HB 2354 (2025), W. Va. Code § 16-7-2(b)(7): banned in food by state law (WV), effective Jan 1, 2028. Under court challenge (enforcement blocked for now): International Association of Color Manufacturers v. Singh.
Products (34)
- ADVANCED CARE+ PREACTIV PREBIOTICS ELECTROLYTE SOLUTION, KIWI BERRY MIST · UPC 70074667799 · FoodData Central record of Mar 19, 2021
B FD&C Blue No. 1 ("blue 1"); B FD&C Yellow No. 6 ("yellow 6") · Report an error - BERRY FROST ADVANCED CARE ELECTROLYTE POWDER, BERRY FROST · UPC 70074674605 · FoodData Central record of Mar 19, 2021
B FD&C Blue No. 1 ("blue 1") · Report an error - BERRY FROST AND STRAWBERRY ELECTROLYTE POWDER, BERRY; STRAWBERRY · UPC 70074685335 · FoodData Central record of Aug 31, 2023
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40") · Report an error - BERRY FROST ELECTROLYTE POWDER, BERRY FROST · UPC 70074669700 · FoodData Central record of Jun 29, 2023
B FD&C Blue No. 1 ("blue 1") · Report an error - BERRY FROST ELECTROLYTE SOLUTION, BERRY FROST · UPC 70074666426 · FoodData Central record of Jun 29, 2023
B FD&C Blue No. 1 ("blue 1") · Report an error - ELECTROLYTE POWDER, CHERRY · UPC 70074645940 · FoodData Central record of Mar 19, 2021
B FD&C Red No. 40 ("red 40") · Report an error - ELECTROLYTE POWDER, ORANGE · UPC 70074641799 · FoodData Central record of Mar 19, 2021
B FD&C Yellow No. 6 ("yellow 6") · Report an error - ELECTROLYTE POWDER, STRAWBERRY LEMONADE · UPC 70074669656 · FoodData Central record of Mar 19, 2021
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40") · Report an error - ELECTROLYTE SOLUTION, BERRY FROST · UPC 70074667768 · FoodData Central record of Mar 19, 2021
B FD&C Blue No. 1 ("blue 1") · Report an error - ELECTROLYTE SOLUTION, CHERRY PUNCH · UPC 70074630588 · FoodData Central record of Jun 29, 2023
B FD&C Red No. 40 ("red 40") · Report an error - ELECTROLYTE SOLUTION, CHERRY PUNCH · UPC 70074667393 · FoodData Central record of Mar 19, 2021
B FD&C Red No. 40 ("red 40") · Report an error - ELECTROLYTE SOLUTION, ICED GRAPE · UPC 70074668567 · FoodData Central record of Mar 19, 2021
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40") · Report an error - FAST HYDRATION GRAPE ELECTROLYTE POWDER, GRAPE · UPC 70074688015 · FoodData Central record of Jun 29, 2023
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40") · Report an error - FAST HYDRATION STRAWBERRY ELECTROLYTE POWDER, STRAWBERRY · UPC 70074687698 · FoodData Central record of Jun 29, 2023
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40") · Report an error - FREEZER POPS ELECTROLYTE SOLUTION, GRAPE; BLUE RASPBERRY; CHERRY; ORANGE · UPC 70074002460 · FoodData Central record of Jun 29, 2023
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40"); B FD&C Yellow No. 6 ("yellow 6") · Report an error - FRUIT PUNCH ELECTROLYTE POWDER, FRUIT PUNCH · UPC 70074679723 · FoodData Central record of Aug 31, 2023
B FD&C Red No. 40 ("red 40") · Report an error - FRUIT PUNCH ELECTROLYTE POWDER, FRUIT PUNCH · UPC 70074688053 · FoodData Central record of Jun 29, 2023
B FD&C Red No. 40 ("red 40") · Report an error - GRAPE ELECTROLYTE POWDER, GRAPE · UPC 70074645971 · FoodData Central record of Jun 29, 2023
B FD&C Blue No. 1 ("blue 1") · Report an error - GRAPE ELECTROLYTE POWDER, GRAPE · UPC 70074666686 · FoodData Central record of Mar 19, 2021
B FD&C Blue No. 1 ("blue 1") · Report an error - GRAPE ELECTROLYTE POWDER, GRAPE · UPC 70074688039 · FoodData Central record of Sep 14, 2023
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40") · Report an error - LEMON LIME ELECTROLYTE SOLUTION, LEMON; LIME · UPC 70074678467 · FoodData Central record of Jun 29, 2023
B FD&C Yellow No. 5 ("yellow 5") · Report an error - LEMON LIME ELECTROLYTE SOLUTIONS, LEMON LIME · UPC 70074678399 · FoodData Central record of Mar 19, 2021
B FD&C Yellow No. 5 ("yellow 5") · Report an error - MIXED BERRY WITH IMMUNE SUPPORT ELECTROLYTE POWDER, MIXED BERRY · UPC 70074679754 · FoodData Central record of Aug 31, 2023
B FD&C Blue No. 1 ("blue 1") · Report an error - ORANGE BREEZE ELECTROLYTE POWDER PACKETS, ORANGE BREEZE · UPC 70074674278 · FoodData Central record of Mar 19, 2021
B FD&C Yellow No. 6 ("yellow 6") · Report an error - ORANGE BREEZE ELECTROLYTE SOLUTION, ORANGE · UPC 70074674353 · FoodData Central record of Jun 29, 2023
B FD&C Yellow No. 6 ("yellow 6") · Report an error - PEACH MANGO WITH IMMUNE SUPPORT ELECTROLYTE SOLUTION, PEACH; MANGO · UPC 70074682129 · FoodData Central record of Jun 29, 2023
B FD&C Yellow No. 6 ("yellow 6") · Report an error - PEDIALYTE ELECTROLYTE POWDER VARIETY PACK, 0.3 OZ, 8 COUNT, STRAWBERRY; FRUIT PUNCH; GRAPE; APPLE · UPC 70074560915 · FoodData Central record of Jul 13, 2023
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40") · Report an error - PREACTIV PREBIOTICS ELECTROLYTE SOLUTION, CHILLED CHERRY POMEGRANATE · UPC 70074666464 · FoodData Central record of Mar 19, 2021
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40") · Report an error - SPORT ELECTROLYTE SOLUTION, BERRY FREEZE, BERRY · UPC 70074684222 · FoodData Central record of May 25, 2023
B FD&C Blue No. 1 ("blue 1") · Report an error - SPORT FRUIT PUNCH ELECTROLYTE SOLUTION, FRUIT PUNCH · UPC 70074678412 · FoodData Central record of Jun 29, 2023
B FD&C Red No. 40 ("red 40") · Report an error - SPORT FRUIT PUNCH ELECTROLYTE SOLUTION, FRUIT PUNCH · UPC 70074678498 · FoodData Central record of Nov 16, 2023
B FD&C Red No. 40 ("red 40") · Report an error - STRAWBERRY FREEZE ELECTROLYTE POWDER, STRAWBERRY · UPC 70074669731 · FoodData Central record of Jun 29, 2023
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40") · Report an error - STRAWBERRY LEMONADE ELECTROLYTE POWDER, STRAWBERRY; LEMONADE · UPC 70074641744 · FoodData Central record of Jun 29, 2023
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40") · Report an error - STRAWBERRY LEMONADE ON-THE-GO ELECTROLYTE POWDER, STRAWBERRY LEMONADE · UPC 70074650517 · FoodData Central record of Mar 19, 2021
B FD&C Blue No. 1 ("blue 1"); B FD&C Red No. 40 ("red 40") · Report an error
Labels change: each row shows the date of its FoodData Central record. A brand that has changed a recipe can report it with "Report an error".
FDA warning letters to Abbott Laboratories Inc, Oct 30, 2021 to Oct 30, 2026
None found from FDA food offices.
FDA notes that later events may have changed the regulatory status of what a letter discusses.