US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 10, 2017 (10 years ago)

RETINOIC ACID all strengths including 0.025%

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: There are also CGMP Deviations.

What was recalled

RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ACID 0.025%/CLINDAMYCIN 1.2% GEL, RETINOIC ACID 0.025%/ HYALURONIC ACID CREAM, RETINOIC ACID 0.05%/HYALURONIC ACID CREAM, RETINOIC ACID 0.1% IN CERAVE CREAM, RETINOIC ACID POWDER 1 GRAM, RETINOIC ACID/HYALURONIC ACID 0.1%/0.1% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Recalling firm
Synergy Rx
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0541-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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Class II · Moderate risk Ongoing

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Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

Heritage Pharmaceuticals Inc NDC 23155-603-51 D-0768-2026
Class III · Low risk Ongoing

Clindamycin Phosphate USP

Reason Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

Sun Pharmaceutical Industries INC NDC 51672-4081-4 D-0257-2026
Class II · Moderate risk Ongoing

Clindamycin HCl Capsule

Reason CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

RemedyRePack Inc. D-0411-2025
Class II · Moderate risk Ongoing

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Reason CGMP Deviations

RemedyRepack Inc. D-0378-2025