CLASS II ONGOING Drug recall · Reported 10 Dec 2025 · FDA Enforcement Report
Wecare Calasoothe recalled by Blossom Pharmaceuticals
Blossom Pharmaceuticals is recalling Wecare Calasoothe, distributed nationwide in the US. The recall was initiated on 31 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0213-2026
- FDA event ID
- 97935
- Recalling firm
- Blossom Pharmaceuticals, Bardej, Goa
- Manufacturer
- Dynarex Corporation
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Oct 2025
- FDA classified
- 2 Dec 2025
- Reported
- 10 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 31 Oct 2025 | Recall initiated by company | |
| 2 Dec 2025 | Classified by FDA | +32 days |
| 10 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations
Product as listed by the FDA
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
cGMP deviations
Which lots are affected?
Lot #: A482305
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 97935This product is part of a recall event; the main page for the event is Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant recalled.
More recalls from Blossom Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | WeCare, Zinc Oxide Ointment recalled by Blossom PharmaceuticalsZinc Oxide | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
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| Drug | CLASS II | Globe Clotrimazole Cream USP, 1 % Antifungal Cream recalledClotrimazole | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nivagen, Zinc Oxide Ointment recalled by Blossom PharmaceuticalsNivagen Zinc Oxide | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lanashield Skin Barrier, Manfuactured recalled | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
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| Drug | CLASS II | Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg) recalledNatural Cherry Honey Herb Throat Drops | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |