Grato Holdings recalls Homeopathic EarAche Drops due to microbial contamination in non-sterile product. Affected bottles have NDC 11822-3644-3 and Lot #G11639. Consumers should check labels for these details.
“Grato Holdings Homeopathic EarAche Drops Recall: Microbial Contamination Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34667-grato-holdings-homeopathic-earache-drops-recall-microbial-contamination-risk. Based on FDA recall #D-0989-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0989-2022%22&limit=1).
The FDA announced on May 24, 2022, that Grato Holdings, Inc. is recalling Homeopathic EarAche Drops due to microbial contamination risks. The voluntary Class II recall affects 16,374 bottles distributed nationwide by Rite Aid.
How to tell if you have it
Brand: Grato Holdings
Product: Homeopathic EarAche Drops
Size: 0.33 FL OZ (10 mL) bottles
NDC: 11822-3644-3
Lot #: G11639
Expiration Date: 09/24
Distributor: Rite Aid
The hazard
The product poses a hazard due to microbial contamination of the non-sterile drops. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Grato Holdings, Inc. has had 8 other recalls on record since December 22, 2015. Other recent recalls of similar products include Energique Mineral Magic Recall (May 3, 2024), Grato Holdings V-FORCE Homeopathic Recall (October 30, 2023), and B-Force Homeopathic Recall (June 18, 2021). Other recent recalls of similar products include Beekeeper's Naturals Saline Nasal Spray Recall (June 1, 2026), Medinatura ReBoost Nasal Spray Recall (December 12, 2025), and Blaine Labs Revitaderm Wound Gel Recall (April 8, 2026).
How to tell if you have this one
Check for bottles labeled 'Homeopathic EarAche Drops, 0.33 FL OZ (10 mL)' with NDC 11822-3644-3 and Lot #G11639. The product was distributed by Rite Aid at the address listed in the recall notice.
Brand
Grato Holdings
Category
Drug
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Nationwide within the USA
Recall number
Product, codes & lots
Quantity
NDC
D-0989-2022
Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3; Lot #: G11639, Exp. Date 09/24
16,374 bottles
11822-3644-3
D-0990-2022
Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15; Lot #: G11639, Exp. Date 09/24
50,640 bottles
—
D-0991-2022
Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15; Lot #: G11639, Exp. Date 09/24
31,872 bottles
0363-3233-15
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the NDC code 11822-3644-3 and Lot #G11639 on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0989-2022 (May 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0989-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.