CORRECTDOSE Children's Allergy Relief Recalled Due to Manufacturing Process Control Deviations
CORRECTDOSE Children's Allergy Relief (Diphenhydramine HCl 12.5 mg per 5 mL) is being recalled nationwide. The FDA determined products were manufactured under conditions with inadequate process control.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a children's medication due to manufacturing process control deviations. The Class II classification indicates potential for adverse health consequences. However, the source does not identify a specific hazard and reports no illnesses or injuries, which limits the score to High per the rubric guidance.
Plain-English summary
CORRECTDOSE Children's Allergy Relief, containing Diphenhydramine HCl 12.5 mg per 5 mL, is subject to a Class II recall. The product was manufactured by Plastikon Healthcare LLC and distributed nationwide by Correct Dose Inc. of Braintree, Massachusetts, under NDC 62320-302-05.
The FDA determined that the products were manufactured under conditions in which manufacturing processes were not adequately controlled, constituting a CGMP (Current Good Manufacturing Practice) deviation.
The recalled product is distributed in 2.04 fl. oz. (60 mL) packages containing twelve 5 mL individual ampoules. The affected lot is Lot #21011A with an expiration date of January 2023, representing approximately 7,200 ampoules distributed nationwide in the United States.
Consumers should not use this recalled product. For return or disposal instructions, consumers should contact Correct Dose Inc., the distributing firm.
The recalled product
- Product
- CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
- Manufacturer
- Plastikon Healthcare LLC
- Hazard
- manufacturing-defect
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 # 21011A
- EXP Jan. 2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateCorlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
FDA (Drugs) · 2026-07-01
- ModerateSensipar cinacalcet hydrochloride tablets recalled for CGMP deviations
FDA (Drugs) · 2026-07-01
- ModerateSensipar Cinacalcet Tablets Recalled Due to CGMP Deviations
FDA (Drugs) · 2026-07-01
- ModerateSensipar (Cinacalcet Hydrochloride) Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2026-07-01